MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER 2.7F SINGLE-LUMEN W/VITACUFF; CHRONIC CATHETERS

Model Number	0600044
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/03/2021
Type of Reportable Event	Serious 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.The investigation of the reported event is currently underway.(expiry date: 08/2022).
Event or Problem Description
It was reported that post chronic catheter placement, the device allegedly fractured.It was further reported that surgery was performed and the line was removed and replaced with a new line.The patient was reportedly stable.
Event or Problem Description
It was reported that seventy one days post port placement procedure, device was allegedly fractured.It was further reported that patient felt pain during infusion.Reportedly, the device was removed and replaced.The current patient status is unknown.
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 in three segments were returned for evaluation.Visual, microscopic visual, functional and tactile evaluation were performed on the returned device.The investigation is confirmed for the reported catheter fracture and identified material separation issue as a complete circumferential break of the catheter was noted to be approximately 20.3cm from the distal end of the luer.The second catheter segment have complete circumferential breaks was noted to be approximately 1.1cm and appeared to at both the distal and proximal ends.The third catheter segment measured approximately 5.9cm and was noted complete circumferential break at one end.A longitudinal split and blood residue, was observed approximately 7mm from the distal end of the catheter segment.Further the edges of the circumferential break were jagged with granular 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: 08/2022), g3, h6 (device).H11: section a through f ¿ the information provide by bd represents all 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.

• Brand Name: BROVIAC CV CATHETER 2.7F SINGLE-LUMEN W/VITACUFF
• Common Device Name: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12457658
• Report Number: 3006260740-2021-03797
• Device Sequence Number: 3964821
• Product Code: LJS
• UDI-Device Identifier: 00801741036316
• UDI-Public: (01)00801741036316
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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: 0600044
• Device Catalogue Number: 0600044
• Device Lot Number: REEW0405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 09/11/2021
• Supplement Report FDA Received Date: 10/13/2021
• 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: Other; Required Intervention
• Patient Age: 4 MO
• Patient Weight: 5