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

Model Number	0600040
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/07/2021
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 06/2021).
Event or Problem Description
It was reported that approximately six hours post a catheter placement procedure in the right internal jugular, the patient allegedly bled.Upon inspection, the catheter was found to be cracked.The device was removed and replaced.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one broviac s/l catheter was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The investigation is confirmed for the reported catheter fracture and fluid leak issue, as a diagonal split was observed approximately 7.2 cm from the distal end of the luer.Two notable features were noted on the edges of the diagonal split; one region of the split had jagged edges while the other region had striations.The catheter was patent to infusion and aspiration; upon infusion of the catheter, a leak from the diagonal split was observed.The definitive root cause could not be determined based upon 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: 06/2021), g3, h6 (device, method).H11: h6 (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.
Event or Problem Description
It was reported that approximately six hours post a catheter placement procedure in the right internal jugular, the patient allegedly bled.Upon inspection, the catheter was found to be cracked.The device was removed and replaced.The current status of the patient is unknown.

• Brand Name: BROVIAC CV CATHETER, SINGLE-LUMEN, 2.7F
• 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: 12164821
• Report Number: 3006260740-2021-02744
• Device Sequence Number: 909522
• Product Code: LJS
• UDI-Device Identifier: 00801741036309
• UDI-Public: (01)00801741036309
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 10/02/2021

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: 0600040
• Device Catalogue Number: 0600040
• Device Lot Number: RECR2130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 10/08/2021
• 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
• Patient Age: 24 DA