MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE BIOGEL; PI PRO-FIT

Model Number 47985-00

Device Problems Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2023

Event Type  malfunction  

Event Description

Facilty reports product labeled as non-latex; however, product found inside contains latex.The patient the gloves were intended for, has a latex allergy.Package 47985 biogel pi pro-fit.Synthetic gloves.Gloves found inside are latex 30485 biogel surgeons latex gloves.The gloves were not used and no harm reported.

Manufacturer Narrative

Investigation / root cause analysis: during running packing lot no.23b0006 biogel surgeons 961 - b17 (latex), there were 30 samples of stratified samples collected for verifying the caught pack issue, instead of 5 packs (required quantity packs).Hence, final pack (shift c) has 25 pairs excess of stratified samples, and the excess of stratified samples were not disposed immediately.Final pack has returned the excess 25 pairs of stratified samples to packing line 11, while packing lot 23b1107, biogel pi pro fit (synthetic), size 8.5.Respective packing personnel was not informed on the returned packs or identified the packs with label or indication.After performed tear open activity, eventually that excess stratified samples mixed with current production run lot 23b1107.Corrective action(s) / preventive actions(s): 1.Review and update the current sop on the ad hoc of the changes of the packing lot size and management of handling stratified sample activity.2.To have 4 teams of packing personnel to handle nr latex product.3.The packing room will only pack nr gloves at one time.

• Brand Name: BIOGEL
• Type of Device: PI PRO-FIT
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE; 5445 triangle parkway; suite 400; peachtree corners GA 30092
• Manufacturer (Section G): MOLNLYCKE HEALTH CARE; 5445 triangle parkway; suite 400; peachtree corners GA 30092
• Manufacturer Contact: mary gill ; 5445 triangle parkway; suite 400; peachtree corners, GA 30092 ; 4706023891
• MDR Report Key: 18449610
• MDR Text Key: 332166547
• Report Number: 3004763499-2024-00001
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 47985-00
• Device Lot Number: 23B1107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1