MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 REPAIR KIT EXTERNAL CATHETER SEGMENT; PORT AND CATHETER ACCESSORIES

Model Number 0601760

Device Problems Backflow (1064); Loss of or Failure to Bond (1068); Reflux within Device (1522); Detachment of Device or Device Component (2907)

Patient Problems Anemia (1706); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical device expiration date: 08/2022.

Event Description

It was reported that three hours post catheter repair procedure, the joining connector of the repair kit was allegedly noted to be detached from the repair site and blood backflow was noted.It was further reported that the patient developed anemia.The catheter was removed and patient reported to be stable after anemia recovery.

Manufacturer Narrative

H10: additional information was received and the file was reassessed for reportability and determined to be reportable as a malfunction.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one bard 7fr d/l catheter was returned for evaluation.Gross, microscopic visual and functional testing were performed.However, the investigation is inconclusive for the reported reflux within the device as the exact circumstances at the time of the reported event cannot be verified and clinical conditions cannot be replicated to confirm these failures.The investigation is confirmed for the reported loss of or failure to bond issue as the distal end of the catheter body appeared to have silicone adhesive material and the inner catheter liners were noted exposed without any damage.Furthermore, the distal catheter segment was not returned for evaluation.Clinical conditions alleged in the complaint cannot be confirmed.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 08/2022), g3, h6 (method).H11: b5, h1, h6 (patient, device, result, conclusion).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 : see h10.

Event Description

It was reported that three hours post catheter repair procedure, the joining connector of the repair kit was allegedly noted to be detached from the repair site and blood backflow was noted.It was further reported that the patient developed anemia.The catheter was removed.There was no reported patient injury.

• Brand Name: REPAIR KIT EXTERNAL CATHETER SEGMENT
• Type of Device: PORT AND CATHETER ACCESSORIES
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13204064
• MDR Text Key: 283481929
• Report Number: 3006260740-2021-05598
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036484
• UDI-Public: (01)00801741036484
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K830406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0601760
• Device Catalogue Number: 0601760
• Device Lot Number: REET2794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• 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
• Patient Age: 3 YR
• Patient Sex: Female