MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 INVIEW SILICONE SELF-ADHESIVE SHEATH; MEC

Catalog Number 97232

Device Problems Expiration Date Error (2528); Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the expiration date of the male external catheter was inconsistent between the labels on the primary box, the secondary packaging, and the certificate of compliance.Per follow up with the complainant by email on (b)(6) 2018 the label that contained the inconsistent expiration date was an additional label that was printed off at the (b)(6) distribution center.These (b)(6) labels were defaulted to list the expiration date on the first day of the month instead of the last, which does not align with bd's expiration date.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation of the photo sample noted that the two expiration dates on the labels did not match.One stated the 1st of december while the second label stated the 28th of december.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿note: do not use on irritated or compromised skin.Do not use if allergic reaction occurs.If sheath has an insert, remove it.Not made with natural rubber latex.".

Event Description

It was reported that the expiration date of the male external catheter was inconsistent between the labels on the primary box, the secondary packaging, and the certificate of compliance.Per follow up with the complainant by email on nov 8 2018 the label that contained the inconsistent expiration date was an additional label that was printed off at the hollister distribution center.These hollister labels were defaulted to list the expiration date on the first day of the month instead of the last, which does not align with bd's expiration date.

• Brand Name: INVIEW SILICONE SELF-ADHESIVE SHEATH
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8098864
• MDR Text Key: 128198230
• Report Number: 1018233-2018-05627
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2022
• Device Catalogue Number: 97232
• Device Lot Number: JUCN0224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Date Manufacturer Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1