Tegaderm™ 1665Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30707387770366), received between Jul 17, 2018 and Sep 12, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE MANAGER REPORTED A PATIENT HAD A PORT NEEDLE SECURED WITH A 1665 3M¿ TEGADERM¿ CHG CHLORHEXIDINE GLUCONATE I. V. PORT DRESSING. THE PATIENT REPORTEDLY EXPERIENCED A PORT NEEDLE DISLODGEMENT WHEN THE PORT WAS ACCESSED IN THE ER. PATIENT SPECIFIC INFORMATION WAS NOT PROVIDED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Reinfusion

  MAUDE report 9009603 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED AN ADULT INPATIENT WAS RECEIVING A BLOOD INFUSION THROUGH THEIR IMPLANTED PORT CATHETER SITE. A 1665 TEGADERM¿ CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING WAS USED TO COVER AND SECURE THE PATIENT'S HUBER NEEDLE. THE HUBER NEEDLE REPORTEDLY BECAME DISLODGED AND THE PATIENT EXPERIENCED AN INFILTRATION OF THE BLOOD INFUSION UNDER THEIR SKIN AT THE PORT SITE. A PERIPHERAL IV SITE WAS USED FOR IV ACCESS WHILE THE IMPLANTED PORT SITE HEALED.

  Patient problems: Infiltration into Tissue

  MAUDE report 8623240 ↗
• InjuryJan 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED HOSPITALIZED ONCOLOGY PATIENTS WERE RECEIVING CHEMOTHERAPY INFUSIONS THROUGH AN IMPLANTED PORT. THE IMPLANTED PORTS WERE ACCESSED WITH A HUBER NEEDLE AND WERE ALLEGEDLY SECURED WITH A 1665 3M¿ TEGADERM¿ CHG CHLORHEXIDINE GLUCONATE I. V. PORT DRESSING. THE NURSE REPORTED SIX PATIENTS EXPERIENCED HUBER NEEDLE DISLODGEMENTS IN THE PAST YEAR. THE PATIENTS REQUIRED REINSERTION OF THEIR HUBER NEEDLES. THE NURSE REPORTED NO OTHER PATIENT CONSEQUENCE/INJURY WAS ASSOCIATED WITH THESE DISLODGEMENTS.

  Patient problems: Reinfusion

  MAUDE report 8273698 ↗
• InjuryJan 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED A HOSPITALIZED ONCOLOGY PATIENT WAS RECEIVING A CHEMOTHERAPY INFUSION THROUGH AN IMPLANTED PORT. THE IMPLANTED PORT WAS ACCESSED WITH A HUBER NEEDLE AND WAS ALLEGEDLY SECURED WITH A 1665 3M¿ TEGADERM¿ CHG CHLORHEXIDINE GLUCONATE I. V. PORT DRESSING. THE NURSE REPORTED THE HUBER NEEDLE BECAME DISLODGED AND THE CHEMOTHERAPY MEDICATION LEAKED ONTO THE PATIENT'S SKIN. THE PATIENT EXPERIENCED A SKIN INJURY THAT RESEMBLED CELLULITIS. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS. THE IMPLANTED PORT CATHETER COULD NOT BE USED. THE PATIENT REQUIRED AN INSERTION OF A PICC LINE TO RESUME THERAPY.

  Patient problems: Cellulitis

  MAUDE report 8273683 ↗
• InjuryJul 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A CUSTOMER REPORTED THE FOLLOWING INFORMATION VIA A MEDWATCH REPORT: ACCESSED PORT ON PEDIATRIC PATIENT USING THE NEW TEGADERM CHG 3M DRESSING. PORT WAS ACCESSED AND DRESSING APPLIED AS TRAINED WITHOUT COMPLICATIONS. PATIENT MEDICATION STARTED AND WAS INFUSING VIA PORT. STEPPED AWAY FROM BEDSIDE TO PREPARE NEXT MEDICATION. FLOOR MA ENTERED THE MED ROOM AND STATED THAT THE PATIENT'S PORT NEEDLE WAS OUT. AS MOM REPORTED, WENT TO THE BEDSIDE AND NEEDLE WAS OUT FROM THE PORT INJECTION SITE UNDER 3M NONADHESIVE PORTION OF THE DRESSING. NEEDLE LAYING AGAINST PATIENT'S CHEST. QUICKLY REMOVED DRESSING AND ASSESSED SITE. PATIENT DOES HAVE 3 RED ROUND MARKS THAT APPEAR TO BE FROM THE NEEDLE POKING THE SKIN UNDER THE NONADHESIVE PORTION. CALLED PROVIDER AND UPDATED ON EVENTS. NEW ORDER FOR MEDICATION WAS NEEDED BECAUSE THE MEDICATION DID NOT INFUSE AS THE NEEDLE WAS DISLODGED. PORT SITE RE-ACCESSED USING STERILE TECHNIQUE DRESSING APPLIED WAS NOT THE CHG DRESSING. DRESSING APPLIED WAS 3M ADHESIVE TEGADERM FILM 1624W. THE DETAILS IN THE REPORT IS THE EXTENT TO WHICH WE IDENTIFY MEDICATIONS INVOLVED OR PATIENT CONTACT.

  Patient problems: Needle Stick/Puncture; Reinfusion

  MAUDE report 7695351 ↗