MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 POP-ON¿ SELF-ADHERING MALE EXTERNAL CATHETER

Model Number 7323

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2022

Event Type  malfunction  

Event Description

It was reported that the patient had noticed a change in the packaging of their sheath.The white plastic was a lot thinner and on the clear plastic side it was very thin and vacuum was packed around the sheath.They also felt that the sheath itself was inferior to what they had been using with and were coming off more frequently.As per sample evaluation results received on (b)(6) 2022, stated that the strong adhesive was found during sample evaluation.

Manufacturer Narrative

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

Manufacturer Narrative

Upon further review, bd has determined that there was no allegation against product.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.

Event Description

It was reported that the patient had noticed a change in the packaging of their sheath.The white plastic was a lot thinner and on the clear plastic side it was very thin and vacuum was packed around the sheath.They also felt that the sheath itself was inferior to what they had been using with and were coming off more frequently.As per sample evaluation results received on 07-dec-2022, stated that the strong adhesive was found during sample evaluation.Per investigator notification received on 03jan2023, stated that the tested sample was within specification and no strong adhesive was found.

• Brand Name: POP-ON¿ SELF-ADHERING MALE EXTERNAL CATHETER
• Type of Device: MALE 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16052462
• MDR Text Key: 308165441
• Report Number: 1018233-2022-09854
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071652
• UDI-Public: (01)00801741071652
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7323
• Device Catalogue Number: 32303
• Device Lot Number: JUGS9026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other