MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. 203 REPAIR 1.00MM-WHITE; CHRONIC CATHETER REPAIR KIT

Model Number	0601620
Medical Device Problem Codes	Fluid/Blood Leak (1250); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one(1) malfunction event.A review of the events indicated that model 0601620 chronic catheter repair kit allegedly found damaged.It was further reported that the damaged section was removed and the catheter was repaired.This report was received from one source.This event involved one patient with no reported patient injury.
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation; the investigation is confirmed for a partial break/split/leak in catheter, as a partial split was observed just proximal to the splice sleeve.The definitive root cause could not be determined based upon available information.
Event or Problem Description
This report summarizes one(1) malfunction event.A review of the events indicated that model 0601620 chronic catheter repair kit allegedly found damaged.It was further reported that the damaged section was removed and the catheter was repaired.This report was received from one source.This event involved one patient with no reported patient injury.The patient age, weight, and sex were not provided.

• Brand Name: 203 REPAIR 1.00MM-WHITE
• Common Device Name: CHRONIC CATHETER REPAIR KIT
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• MDR Report Key: 8525532
• Report Number: 3006260740-2019-00920
• Device Sequence Number: 2798794
• Product Code: LJS
• UDI-Device Identifier: 00801741074479
• UDI-Public: (01)00801741074479
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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: No Information
• Device Model Number: 0601620
• Device Catalogue Number: 0601620
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 07/24/2019
• Patient Sequence Number: 1