MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 REPAIR WHITE ADAPTER LEG; PORT AND CATHETER ACCESSORIES

Model Number	0601680
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiration date: 07/2023).
Event or Problem Description
It was reported that approximately seven months post catheter repair placement, the catheter allegedly had hole.It was further reported that the catheter allegedly got ballooned while flushing and the catheter allegedly leaked.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one repair kit s/l catheter was returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.A complete circumferential break was noted on the distal end of the catheter.However, striations were noted throughout the surface.The investigation is confirmed for the reported material puncture/hole and fluid leak issues, as splits were noted on the catheter approximately 0.4cm from the clamping sleeve.Upon application of hydrostatic pressure at the distal end, leaks from the splits on the catheter were observed.The investigation is inconclusive for the reported stretched and ballooning issues, as the exact circumstances at the time of the reported event cannot be verified, and the reported event could not be reproduced in the lab.A definitive root cause could not be determined based upon the 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 (expiration date: 07/2023), g3.H11: h6 (method, 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 or Problem Description
It was reported that approximately seven months post catheter repair placement, the catheter allegedly had a hole.It was further reported that the catheter allegedly got ballooned while flushing and the catheter allegedly leaked.There was no reported patient injury.

• Brand Name: REPAIR WHITE ADAPTER LEG
• Common Device Name: 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15173337
• Report Number: 3006260740-2022-03066
• Device Sequence Number: 6288716
• Product Code: LJS
• UDI-Device Identifier: 00801741036415
• UDI-Public: (01)00801741036415
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K830406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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 Model Number: 0601680
• Device Catalogue Number: 0601680
• Device Lot Number: REFS4497
• 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: 07/13/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown