MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 210 REPAIR 1.6MM-WHITE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0601630
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Sepsis (2067); No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.
Event or Problem Description
It was reported that approximately one month post central venous catheter placement, allegedly a puncture was identified next to the hub and the line was repaired.Reportedly, the patient was hospitalized for sepsis and placed on peripheral intravenous cannulation for fluids and antibiotics.The device was removed and replaced.The current patient status is unknown.
Event or Problem Description
It was reported that approximately one month post chronic catheter repair placement, the catheter repair segment allegedly had a puncture at the end of the silicon catheter next to the hard plastic white lumen.It was further reported that another repair kit was placed.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown.Investigation summary: one s/l hickman extension leg was returned corresponding to this event.An s-shaped split of the inner lumen was observed immediately distal to the clamp sleeve with the outer catheter completely broken at the site of the split.Leaking was also identified from the site of the split during an infusion test.When viewed under magnification, the surface of the split was noted to be mainly smooth with some granularity observed near the center.Tensile weakness was also observed based on these findings, the investigation is confirmed for the reported catheter break.Per the evaluation results, the inner lumen split was noted to be s-shaped with some granularity in the split surface and tensile weakness observed.These are characteristics typical of burst damage.As such, it is possible that over-pressurization contributed to the reported event.However, the definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Potential contributing factors include flushing against an occlusion, flushing with the wrong size of syringe, material fatigue and chemical degradation.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• Brand Name: 210 REPAIR 1.6MM-WHITE
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8294135
• Report Number: 3006260740-2019-00124
• Device Sequence Number: 19255221
• Product Code: LJS
• UDI-Device Identifier: 00801741036408
• UDI-Public: (01)00801741036408
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K830406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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 Model Number: 0601630
• Device Catalogue Number: 0601630
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 04/03/2019
• 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: Hospitalization
• Patient Age: 5 YR