McKesson S8665GRecalls & reported problems
Mckesson Medical-Surgical Inc. · SUTURE, PROLENE BLU MONO 3-0 18" FS-2 (12/BX) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10612479213514), received between Nov 1, 2023 and Nov 2, 2023 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 reports).
1 other recall cover devices cleared under the same FDA submission (K954808); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component12
Patient problems
- Insufficient Information12
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THERE WERE 12 SUTURES IN ONE BOX THAT WERE NOT ATTACHED TO THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 18060415 ↗MalfunctionNov 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THERE WERE 12 SUTURES IN ONE BOX THAT WERE NOT ATTACHED TO THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 18060242 ↗MalfunctionNov 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THERE WERE 12 SUTURES IN ONE BOX THAT WERE NOT ATTACHED TO THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 18060072 ↗MalfunctionNov 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THERE WERE 12 SUTURES IN ONE BOX THAT WERE NOT ATTACHED TO THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 18059863 ↗MalfunctionNov 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THERE WERE 12 SUTURES IN ONE BOX THAT WERE NOT ATTACHED TO THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 18059695 ↗MalfunctionNov 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THERE WERE 12 SUTURES IN ONE BOX THAT WERE NOT ATTACHED TO THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 18059547 ↗MalfunctionNov 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THERE WERE 12 SUTURES IN ONE BOX THAT WERE NOT ATTACHED TO THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 18059535 ↗MalfunctionNov 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THERE WERE 12 SUTURES IN ONE BOX THAT WERE NOT ATTACHED TO THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 18059429 ↗MalfunctionNov 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THERE WERE 12 SUTURES IN ONE BOX THAT WERE NOT ATTACHED TO THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 18049322 ↗MalfunctionNov 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THERE WERE 12 SUTURES IN ONE BOX THAT WERE NOT ATTACHED TO THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 18048727 ↗MalfunctionNov 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THERE WERE 12 SUTURES IN ONE BOX THAT WERE NOT ATTACHED TO THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 18048673 ↗MalfunctionNov 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THERE WERE 12 SUTURES IN ONE BOX THAT WERE NOT ATTACHED TO THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 18048612 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K954808. One submission often covers many models, so check the product and lot details in each record.
- Z-1179-2023 · Dec 2, 2022 · Open, ClassifiedSurgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP
Other Suture, Nonabsorbable, Synthetic, Polypropylene devices
- PROLENE 8706HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 recalls294 reports
- PROLENE 8702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths254 reports
- PROLENE 8556HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death240 reports
- PROLENE 8805HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
- PROLENE 8521HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths183 reports
- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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