NIPRO HYPODERMIC NEEDLE AH+2219Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00383790001977), received between Oct 24, 2019 and Oct 25, 2019 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2019Break; Material Fragmentation; Break; Material Fragmentation

  THE HYPODERMIC NEEDLE BROKE OFF AT THE JUNCTION WITH THE HUB DURING USE, DOG DIDN'T MOVE WHEN THE NEEDLE WAS INSERTED, THE NEEDLE BURIED ITSELF UNDER THE SKIN INTO SOFT TISSUE. AFTER MANIPULATING THE AREA FOR A WHILE, THE NEEDLE PUNCTURED BACK THROUGH THE SKIN. ONE STAFF HELD THE SKIN AND THE OTHER USED FORCEPS TO GRASP THE TIP AND PULL THE NEEDLE OUT. ACTUAL PRODUCT CODE IS UNKNOWN. FACILITY DISTRIBUTOR DOES NOT RECORD PRODUCT SHIPPED TO THEIR CUSTOMER. PRODUCT CODE AND LOT IS OBTAIN ONLY IF THE CUSTOMER REPORTS A COMPLAINT. CUSTOMER DID NOT REPORT THIS INCIDENT TO THEIR DISTRIBUTOR, AND THEY DID NOT RETAIN PRODUCT INFORMATION EITHER. SINCE THIS IS THE SAME CUSTOMER FROM THE PREVIOUS COMPLAINT, AND THEY REPORTED PRODUCT CODE AH+2219-1M FOR THE PREVIOUS INCIDENT, WE RAN A REPORT TO PULL LOTS FOR THIS CODE (AH+2219-1M), SHIPPED TO THEIR DISTRIBUTOR. POSSIBLE LOTS ARE: 17L06, 18A10, 18B08, 18B08, 18D20.

  Patient problems: Foreign Body In Patient

  MAUDE report 9242176 ↗
• MalfunctionOct 25, 2019Break; Material Fragmentation; Break; Material Fragmentation

  THE HYPODERMIC NEEDLE BROKE OFF AT THE JUNCTION WITH THE HUB DURING USE, PART OF THE NEEDLE WAS STILL VISIBLE AND STAFF WAS TO EXTRACT THE NEEDLE WITH FORCEPS. ACTUAL PRODUCT CODE IS UNKNOWN. FACILITY DISTRIBUTOR DOES NOT RECORD PRODUCT SHIPPED TO THEIR CUSTOMER. PRODUCT CODE AND LOT IS OBTAIN ONLY IF THE CUSTOMER REPORTS A COMPLAINT. CUSTOMER DID NOT REPORT THIS INCIDENT TO THEIR DISTRIBUTOR, AND THEY DID NOT RETAIN PRODUCT INFORMATION EITHER. SINCE THIS IS THE SAME CUSTOMER FROM THE PREVIOUS COMPLAINT, AND THEY REPORTED PRODUCT CODE AH+2219-1M FOR THE PREVIOUS INCIDENT, WE RAN A REPORT TO PULL LOTS FOR THIS CODE (AH+2219-1M), SHIPPED TO THEIR DISTRIBUTOR. POSSIBLE LOTS ARE: 17L06, 18A10, 18B08, 18B08, 18D20.

  Patient problems: Foreign Body In Patient

  MAUDE report 9242097 ↗
• MalfunctionOct 25, 2019Break; Material Fragmentation; Break; Material Fragmentation

  THE HYPODERMIC NEEDLE BROKE OFF AT THE JUNCTION WITH THE HUB DURING USE, PART OF THE NEEDLE WAS STILL VISIBLE AND STAFF WAS TO EXTRACT THE NEEDLE WITH FORCEPS. ACTUAL PRODUCT CODE IS UNKNOWN. FACILITY DISTRIBUTOR DOES NOT RECORD PRODUCT SHIPPED TO THEIR CUSTOMER. PRODUCT CODE AND LOT IS OBTAIN ONLY IF THE CUSTOMER REPORTS A COMPLAINT. CUSTOMER DID NOT REPORT THIS INCIDENT TO THEIR DISTRIBUTOR, AND THEY DID NOT RETAIN PRODUCT INFORMATION EITHER. SINCE THIS IS THE SAME CUSTOMER FROM THE PREVIOUS COMPLAINT, AND THEY REPORTED PRODUCT CODE AH+2219-1M FOR THE PREVIOUS INCIDENT, WE RAN A REPORT TO PULL LOTS FOR THIS CODE (AH+2219-1M), SHIPPED TO THEIR DISTRIBUTOR. POSSIBLE LOTS ARE: 17L06, 18A10, 18B08, 18B08, 18D20.

  Patient problems: Foreign Body In Patient

  MAUDE report 9241972 ↗
• MalfunctionOct 25, 2019Break; Material Fragmentation; Break; Material Fragmentation

  THE HYPODERMIC NEEDLE THE HYPODERMIC NEEDLE BROKE OFF AT THE JUNCTION WITH THE HUB DURING USE, PART OF THE NEEDLE WAS STILL VISIBLE AND STAFF WAS TO EXTRACT THE NEEDLE WITH FORCEPS. EXACT DATE OF EVENT IS UNKNOWN (BETWEEN (B)(6) AND (B)(6) 2019). ACTUAL PRODUCT CODE IS UNKNOWN. FACILITY DISTRIBUTOR DOES NOT RECORD PRODUCT SHIPPED TO THEIR CUSTOMER. PRODUCT CODE AND LOT IS OBTAIN ONLY IF THE CUSTOMER REPORTS A COMPLAINT. CUSTOMER DID NOT REPORT THIS INCIDENT TO THEIR DISTRIBUTOR, AND THEY DID NOT RETAIN PRODUCT INFORMATION EITHER. SINCE THIS IS THE SAME CUSTOMER FROM THE PREVIOUS COMPLAINT, AND THEY REPORTED PRODUCT CODE AH+2219-1M FOR THE PREVIOUS INCIDENT, WE RAN A REPORT TO PULL LOTS FOR THIS CODE (AH+2219-1M), SHIPPED TO THEIR DISTRIBUTOR. POSSIBLE LOTS ARE: 17L06, 18A10, 18B08, 18B08, 18D20.

  Patient problems: Foreign Body In Patient

  MAUDE report 9241890 ↗
• MalfunctionOct 25, 2019Break; Material Fragmentation; Break; Material Fragmentation

  THE HYPODERMIC NEEDLE BROKE OFF AT THE JUNCTION WITH THE HUB DURING USE. THE CAT REACTED MILDLY WHEN THE NEEDLE WAS INSERTED. THE NEEDLE FULLY EMBEDDED IN THE SOFT TISSUE. STAFF WAS ABLE TO MANIPULATE THE AREA, THE NEEDLE PUNCTURED BACK THROUGH THE SKIN, STAFF EXTRACTED THE NEEDLE. ACTUAL PRODUCT CODE IS UNKNOWN. FACILITY DISTRIBUTOR DOES NOT RECORD PRODUCT SHIPPED TO THEIR CUSTOMER. PRODUCT CODE AND LOT IS OBTAIN ONLY IF THE CUSTOMER REPORTS A COMPLAINT. CUSTOMER DID NOT REPORT THIS INCIDENT TO THEIR DISTRIBUTOR, AND THEY DID NOT RETAIN PRODUCT INFORMATION EITHER. SINCE THIS IS THE SAME CUSTOMER FROM THE PREVIOUS COMPLAINT, AND THEY REPORTED PRODUCT CODE AH+2219-1M FOR THE PREVIOUS INCIDENT, WE RAN A REPORT TO PULL LOTS FOR THIS CODE (AH+2219-1M), SHIPPED TO THEIR DISTRIBUTOR. POSSIBLE LOTS ARE: 17L06, 18A10, 18B08, 18B08, 18D20.

  Patient problems: Foreign Body In Patient

  MAUDE report 9241798 ↗
• MalfunctionOct 25, 2019Break; Material Fragmentation; Break; Material Fragmentation

  THE HYPODERMIC NEEDLE BROKE OFF AT THE JUNCTION WITH THE HUB DURING USE. THE CAT DID NOT MOVE WHEN THE NEEDLE WAS INSERTED INTO THE SKIN AND THE NEEDLE STILL BROKE. THE NEEDLE WAS STILL STICKING OUT THE OF SKIN AND WAS ABLE TO BE REMOVED WITH FORCEPS. ACTUAL PRODUCT CODE IS UNKNOWN. FACILITY DISTRIBUTOR DOES NOT RECORD PRODUCT SHIPPED TO THEIR CUSTOMER. PRODUCT CODE AND LOT IS OBTAIN ONLY IF THE CUSTOMER REPORTS A COMPLAINT. CUSTOMER DID NOT REPORT THIS INCIDENT TO THEIR DISTRIBUTOR, AND THEY DID NOT RETAIN PRODUCT INFORMATION EITHER. SINCE THIS IS THE SAME CUSTOMER FROM THE PREVIOUS COMPLAINT, AND THEY REPORTED PRODUCT CODE AH+2219-1M FOR THE PREVIOUS INCIDENT, WE RAN A REPORT TO PULL LOTS FOR THIS CODE (AH+2219-1M), SHIPPED TO THEIR DISTRIBUTOR. POSSIBLE LOTS ARE: 17L06, 18A10, 18B08, 18B08, 18D20.

  Patient problems: Foreign Body In Patient

  MAUDE report 9241696 ↗
• MalfunctionOct 25, 2019Break; Material Fragmentation; Break; Material Fragmentation

  THE HYPODERMIC NEEDLE BROKE OFF AT THE JUNCTION WITH THE HUB DURING USE. THE NEEDLE WORKED ITSELF INTO THE MUSCLE OF THE BACK LEG OF THE CAT. THE CAT HAD TO BE REFERRED TO A PRIVATE PRACTICE FOR REMOVAL OF THE NEEDLE DUE TO THE PROXIMITY TO THE FEMORAL NERVE AND ARTERY. ACTUAL PRODUCT CODE IS UNKNOWN. FACILITY DISTRIBUTOR DOES NOT RECORD PRODUCT SHIPPED TO THEIR CUSTOMER. PRODUCT CODE AND LOT IS OBTAIN ONLY IF THE CUSTOMER REPORTS A COMPLAINT. CUSTOMER DID NOT REPORT THIS INCIDENT TO THEIR DISTRIBUTOR, AND THEY DID NOT RETAIN PRODUCT INFORMATION EITHER. SINCE THIS IS THE SAME CUSTOMER FROM THE PREVIOUS COMPLAINT, AND THEY REPORTED PRODUCT CODE AH+2219-1M FOR THE PREVIOUS INCIDENT, WE RAN A REPORT TO PULL LOTS FOR THIS CODE (AH+2219-1M), SHIPPED TO THEIR DISTRIBUTOR. POSSIBLE LOTS ARE: 17L06, 18A10, 18B08, 18B08, 18D20.

  Patient problems: Foreign Body In Patient

  MAUDE report 9241473 ↗
• MalfunctionOct 24, 2019Break; Material Fragmentation; Break; Material Fragmentation

  THE HYPODERMIC NEEDLE BROKE OFF AT THE HUB DURING USE, WHEN ATTEMPTING TO SEDATE THE ANIMAL. THE BROKEN NEEDLE HAD TO BE REMOVED FROM THE ANIMAL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9235673 ↗
• InjuryOct 24, 2019Break

  THE HYPODERMIC NEEDLE BROKE OFF AT THE HUB DURING USE, WHEN ATTEMPTING TO SEDATE THE ANIMAL. THE BROKEN NEEDLE HAD TO BE REMOVED FROM THE ANIMAL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9235628 ↗