MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® CLEAN-CATH® INTERMITTENT CATHETER; VINYL CATHETER

Model Number	421712
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Muscle Spasm(s) (1966); Pain (1994); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that upon removal of the catheter, the white tip came out only leaving the remainder of the catheter indwelled.The patient went to the hospital 8 hours away to have the catheter fully removed.Reportedly, the catheter was removed surgically by a urologist.The patient was at home, but alleged bladder spasms.Per additional information received via email on 18 march 2020 from ibc representative, a cystoscopy was performed on the patient to remove the catheter.The catheter was in two pieces, and it was removed by a physician.The patient went to the emergency department that same night, and was prescribed ciprofloxacin 500mg.The patient was also prescribed morphine for pain.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿tip breaks¿ with a potential root cause of "material weakens over time".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: "visually inspect the product for any imperfections or surface deterioration prior to use.This is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of device, which may lead to device failure, and/or lead to injury, illness or death of the patient." correction: d4 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 device was not returned.
Event or Problem Description
It was reported that upon removal of the catheter, the white tip came out only leaving the remainder of the catheter indwelled.The patient went to the hospital (b)(4) hours away to have the catheter fully removed.Reportedly, the catheter was removed surgically by a urologist.The patient was at home, but alleged bladder spasms.Per additional information received via email on (b)(6)2020 from ibc representative, a cystoscopy was performed on the patient to remove the catheter.The catheter was in two pieces, and it was removed by a physician.The patient went to the emergency department that same night, and was prescribed ciprofloxacin 500mg.The patient was also prescribed morphine for pain.

• Brand Name: BARD® CLEAN-CATH® INTERMITTENT CATHETER
• Common Device Name: VINYL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9915392
• Report Number: 1018233-2020-02245
• Device Sequence Number: 14157532
• Product Code: KOD
• UDI-Device Identifier: 00801741038815
• UDI-Public: (01)00801741038815
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K802665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2024
• Device Model Number: 421712
• Device Catalogue Number: 421712
• Device Lot Number: NGDV0310
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention