MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC POP-ON M 30BX

Catalog Number 32302

Device Problems Inadequate Instructions for Healthcare Professional (1319); Device Markings/Labelling Problem (2911)

Patient Problems No Consequences Or Impact To Patient (2199); 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 product wrap did not match the control labeling.Per follow up with the complainant by email on mar 11 2019, the control label (bd/bard (b)(4) applied label) and the country specific label ((b)(6) distribution center applied label) did not match.The country specific label was found to be incorrect.

Event Description

It was reported that the product wrap did not match the control labeling.Per follow up with the complainant by email on mar 11 2019, the control label (bd/bard juarez applied label) and the country specific label (hollister distribution center applied label) did not match.The country specific label was found to be incorrect.

Manufacturer Narrative

The reported event was inconclusive.Visual evaluation of the photo sample noted that the sample was a photo copy of two labels.Although the labels do differ in product codes, it was unable to be determined if these were in fact from the same box, or what product was intended to be received.The results of the investigation will be inconclusive due to poor sample condition.A potential root cause could be incorrect print plate used.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: "instructions for silicone self-adhesive sheath note: do not use on irritated or compromised skin.Do not use if allergic reaction occurs.If sheath has an insert, remove it (figures 1 & 2).Application: figures 3 & 4.Removal: figure 5.Not made with natural rubber latex.".

• Brand Name: ROCHESTER MEC POP-ON M 30BX
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8434522
• MDR Text Key: 139423503
• Report Number: 1018233-2019-01441
• 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: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• 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: 32302
• Device Lot Number: JUBZ0397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1