MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK FEMALE EXTERNAL CATHETER

Model Number	PWF030F
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
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 customer received a bunch of purewick female external catheter in a zip lock bag but not the purewick package that had the directions for use on it.Per additional information received via email on 23nov2022, it was reported that the purewick female external catheter came in zip-log bags rather than packaged individually.While these were not sterile, they were considered clean, and storing them this way could affect their cleanliness.This was not normal, there was no plan to change the packaging, and they were working with medline to return the product.
Event or Problem Description
It was reported that the customer received a bunch of purewick female external catheter in a zip lock bag but not the purewick package that had the directions for use on it.Per additional information received via email on 23nov2022, it was reported that the purewick female external catheter came in zip-log bags rather than packaged individually.While these were not sterile, they were considered clean, and storing them this way could affect their cleanliness.This was not normal, there was no plan to change the packaging, and they were working with medline to return the product.
Additional Manufacturer Narrative
The reported event is inconclusive, due to poor sample.A photo sample was returned showing multiple purewick female external catheters in a clear plastic bag.As it is unknown if this is how the product was received by the customer, the reported event is inconclusive.Potential cause of the failure is incompatible packaging and ink material - printed label fades or rubs off.Inadequate label contents.The results of the dhr review did not show any problems or conditions that would have contributed to the reported issue.As labeling would not have contributed to the reported event, it is not required.H11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was inspected.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Common Device Name: PUREWICK FEMALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15893439
• Report Number: 1018233-2022-09162
• Device Sequence Number: 5209736
• Product Code: NZU
• UDI-Device Identifier: 00801741163081
• UDI-Public: (01)00801741163081
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: 05/28/2024
• Device Model Number: PWF030F
• Device Catalogue Number: PWF030F
• Device Lot Number: JUGT0216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female