MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC POP-ON L 100BX

Model Number	32104
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that the mec sheath was not able to be rolled down.Per email attached, the mec adheres to the patient's penis causing discomfort upon removal.
Additional Manufacturer Narrative
The reported event was unconfirmed as the problem could not be reproduced.Visual inspection noted 200 unopened pop-on mecs were received.Visual evaluation noted no obvious defects with further testing required.The adhesive peel test was performed per procedure.The samples were cut to the required width (0.70" +/- 0.05") and the adhesive peel strength was found to be within specification (0.80-2.80lbf).One sample broke the frame and did not generate a result, therefore an additional sample was tested.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: "directions: to remove gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the mec sheath was not able to be rolled down.Per email attached, the mec adheres to the patient's penis causing discomfort upon removal.

• Brand Name: ROCHESTER MEC POP-ON L 100BX
• Common Device Name: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9497568
• Report Number: 1018233-2019-08107
• Device Sequence Number: 379525
• Product Code: NNX
• UDI-Device Identifier: 00801741070501
• UDI-Public: (01)00801741070501
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2022
• Device Model Number: 32104
• Device Catalogue Number: 32104
• Device Lot Number: JUBR0834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1