MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® ALL PURPOSE URETHRAL CATHETER

Model Number	0094160
Medical Device Problem Codes	Material Fragmentation (1261); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
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 red rubber intermittent catheter appeared to be breaking down around the eyes.It was stated that safety concern was noticed prior to use.
Event or Problem Description
It was reported that the red rubber intermittent catheter appeared to be breaking down around the eyes.It was stated that safety concern was noticed prior to use.Per additional information received via sample return on 24may2022, it was reported that the red rubber breakdown around eyes.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.Four unopened all purpose catheters were returned.Signs of degradation due to oxidation were present on the funnel end, around the eyelets, and along the shaft of each catheters.As it is unknown when the oxidation occurred or how the catheter was being stored, this event will be confirmed cause unknown.Using a french gauge, the catheters were confirmed to be 16fr and within specifications which states, "french size specification is ±1 french size.".A smooth lump was noted on the funnel end of catheter 4.Using a caliper, the lump on the funnel end of catheter 4 was measured and was 0.301" long and 0.218" wide from the tip.As the smooth lump was on the funnel of the catheter and did not affect the french size of the catheter, the device was still within specifications which states, "smooth lumps no larger than two french sizes are allowed on shaft.No lumps are allowed along the first eight inches from the tip." "no sharp lumps are allowed." 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: "storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Keep away from sunlight".Corrections: d, f, g, h.H11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARD® ALL PURPOSE URETHRAL CATHETER
• 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: 14496600
• Report Number: 1018233-2022-04088
• Device Sequence Number: 6009321
• Product Code: KOD
• UDI-Device Identifier: 00801741034039
• UDI-Public: (01)00801741034039
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 09/27/2022

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: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 0094160
• Device Catalogue Number: 0094160
• Device Lot Number: NGEP4377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2020
• 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