MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE BIOGEL; PI ULTRATOUCH

Model Number 41175-00

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

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

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation ongoing to confirm reported malfunction.The reported event has not lead to an death or serious injury; however, if confirmed, the reported event could have led to a serious injury.Additional report will be filed after investigation is completed or within the applicable time frame, whichever comes first.

Event Description

A physician retrieved a package of sterile non-latex gloves for a cardiac cath procedure on (b)(6) 2023.Upon opening the gloves, it was noticed that the inner paper package was labeled as latex gloves which did not match the outer package label of non-latex.The glove supply was searched in the cath lab and one additional package was found.The procedure was completed without reported delays or harm.The glove supply across the hospital was assessed and no additional aberrant gloves were found.Samples have been returned to the manufacturer and an investigation is in process.

Manufacturer Narrative

Sample testing: there were 6 packs of returned samples received.One of the returned packs has nrl inner wrap with nrl gloves (size 7.5) packed in the package.The remaining packs and retention samples (2 packs) were not having similar abnormalities.Investigation/root cause analysis: the lot size for packing lot no.23f6016 biogel surgeons 304 - a15 (latex) was increased from 60k pairs to 75k pairs during the middle of production run (shift c), to meet the business order.The stratified samples quantity collected at final pack was 45 pairs before increasing the lot size, but the required quantity was 38 pairs for size 7.5.Hence, final pack (shift a) has 7 pairs excess of stratified samples, and the excess stratified samples were not disposed immediately.Final pack has returned the excess 7 pairs of stratified samples to packing line 3, while the line is running lot 23f4600, biogel pi ultra touch (synthetic), size 7.5.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 23f4600.Corrective action(s)/preventive actions(s): corrective action(s): 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.To have 4 teams of packing personnel to handle nr latex product.The packing room will only pack nr gloves at one time.

• Brand Name: BIOGEL
• Type of Device: PI ULTRATOUCH
• 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: 18341624
• MDR Text Key: 330769219
• Report Number: 3004763499-2023-00002
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 41175-00
• Device Lot Number: 23F4600
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2023
• 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
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Race: White