MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 29MM 100BX; MALE EXTERNAL CATHETER

Model Number	39102
Health Effect - Clinical Code	No Information (3190)
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 complainant received a box for product catalog number 39102 with corporate lot number jubt1749 and that the product within the box was product catalog number 37104 with corporate lot number jubt1749.
Additional Manufacturer Narrative
The reported issue was confirmed.The device was returned for evaluation.Visual inspection noted that all samples received are product 37104.The printed product catalog was different in all packages.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.During the inspection of the labeling of the package it was noted that the printed product catalog was different in all packages.Therefore, the labeling was found inadequate.(b)(4).
Event or Problem Description
It was reported that the complainant received a box for product catalog number 39102 with corporate lot number jubt1749 and that the product within the box was product catalog number 37104 with corporate lot number jubt1749.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 29MM 100BX
• Common Device Name: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7027336
• Report Number: 1018233-2017-05849
• Device Sequence Number: 944221
• Product Code: NNX
• UDI-Device Identifier: 00801741071287
• UDI-Public: (01)00801741071287
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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: Other
• Device Expiration Date: 05/28/2022
• Device Model Number: 39102
• Device Catalogue Number: 39102
• Device Lot Number: JUBT1749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1