MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® URETHRAL CATHETER ROBINSON MODEL

Model Number	056118
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
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 packaging of 2 intermittent catheters were ripped and hence, the catheters became unsterile.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.One sample was confirmed to exhibit the reported failure.The device had not met specifications.Visual evaluation of the returned sample noted one opened (with original packaging), ureteral catheter.Visual inspection of the sample noted the catheter strip packaging was torn and opened upon return.This is out of specification per inspection procedure, which states, "holes / broken / open seals in package are not allowed." a potential root cause for this failure could be inappropriate package design; aggressive handling; inadequate packaging design; with product enclosed, packaging peel strength is insufficient to maintain package integrity; material quality is not acceptable (pinholes, etc.); product packaging obviously not sealed or torn,that is out of box failure"; insufficient package design that does not protect the product from elements during shipping and storage; and/or sharps (external).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labeling could not have prevented the reported failure.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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the packaging of 2 intermittent catheters were ripped and hence, the catheters became unsterile.Per sample received on (b)(6) 2022, it was noted that the intermittent catheters were returned for evaluation.Per additional information received via sample form on (b)(6) 2022, customer stated that wrapper of the intermittent catheters had tears which resulted in the catheters becoming unsterile.Stated that the second catheter had the same result and no further issues.

• Brand Name: BARDEX® URETHRAL CATHETER ROBINSON MODEL
• Common Device Name: URETHRAL 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: 13710268
• Report Number: 1018233-2022-01171
• Device Sequence Number: 12095373
• Product Code: KOD
• UDI-Device Identifier: 00801741033544
• UDI-Public: (01)00801741033544
• 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: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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: Lay User/Patient
• Device Expiration Date: 07/31/2026
• Device Model Number: 056118
• Device Catalogue Number: 056118
• Device Lot Number: NGFW0684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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: Unknown