MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4.2F BROVIAC CV CATHETERS 0.7 MM LUMEN (WHITE ADAPTER) REPAIR KIT; INTRAVASCULAR CATHETER REPAIR KIT

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of ballooning during infusion could be confirmed based on the evidence found on the returned sample.The cause was determined to be related to use of the device.The external segment of a broviac 4.2 fr repair catheter was returned for investigation.The tubing extended 7mm from the distal end of the clamping oversleeve.The printing on the clamping sleeve was completely worn near the crimp collar, which is indicative of clamping near the crimp collar.A breach in the circumferential direction was located within the inner layer of tubing that coincided with the distal tip of the luer adaptor stem.It appears that the inner layer of tubing wore against the luer adaptor stem.Clamping the catheter near the crimp collar or repeatedly flexing or kinking the catheter in the area can stress the catheter as it is stretched over the luer adaptor barb, eventually leading to catheter failure.The catheter should never be clamped over the reinforced segment directly adjacent to the connector.The breach would have allowed fluid to fill the space between the clamping sleeve and the inner tubing and lead to ballooning of the clamping sleeve; however, a hole was found in the tubing that also coincided with the distal tip of the luer adaptor stem.After wearing through the inner tubing, the stem also wore through the clamping sleeve, which appears to have been caused by clamping near the crimp collar.No damage or defects related to the manufacturing process were noted on the returned sample.The damage appears to be associated with use of the device.A lot history review (lhr) review is not possible; the manufacturing lot number that was provided is incorrect.

Event Description

It was reported by the facility that the broviac ballooned during infusion; as it was used for tpn administration.It was stated that the catheter had been repaired twice before and is now going to be replaced.

• Brand Name: 4.2F BROVIAC CV CATHETERS 0.7 MM LUMEN (WHITE ADAPTER) REPAIR KIT
• Type of Device: INTRAVASCULAR CATHETER REPAIR KIT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6584614
• MDR Text Key: 75925912
• Report Number: 3006260740-2017-00670
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036385
• UDI-Public: (01)00801741036385
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/23/2017

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0601610
• Device Lot Number: HUAV_2116 (INCORRECT)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 22 MO