MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC 6.6 F SINGLE-LUMEN CV CATHETER; CHRONIC CATHETERS

Model Number	0600120
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that approximately five months post catheter placement procedure, catheter allegedly damaged by scratching.It was further reported that patient allegedly developed skin reactions due to dressings.There was no reported patient injury.
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.However, photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2026).
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 broviac s/l catheter was returned for evaluation.Gross, microscopic visual, tactile evaluation and functional testing were performed.In addition to the returned physical sample, one electronic photo was provided for review.The investigation is confirmed for the reported catheter fragmentation issue as a small portion of the catheter was noted to be peeled off approximately 1.3cm from the tissue cuff.During tactile evaluation, the catheter felt normally elastic.No evidence indicating loose fitting was noted near the tissue cuff.Furthermore, a complete circumferential break was noted on the distal end of the catheter that was elliptical in shape and striations were noted on the surface.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(expiry date: 04/2026).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 five months post catheter placement procedure, catheter allegedly damaged by scratching.It was further reported that patient allegedly developed skin reactions due to dressings.There was no reported patient injury.

• Brand Name: BROVIAC 6.6 F SINGLE-LUMEN CV CATHETER
• Common Device Name: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15137279
• Report Number: 3006260740-2022-02988
• Device Sequence Number: 5614591
• Product Code: LJS
• UDI-Device Identifier: 00801741051715
• UDI-Public: (01)00801741051715
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K830256
• 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): 10/06/2022

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: 0600120
• Device Catalogue Number: 0600120
• Device Lot Number: HUFS2039
• 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: 07/07/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 11/14/2022
• 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