MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 215 REPAIR 0.7MM-WHITE; INTRAVASCULAR CATHETER REPAIR KIT

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2017

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of huaw2254 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported by the facility that the patient was brought to the clinic on (b)(6) 2017 by his parents for repair of a line that was noted to be ballooning at home.The line was repaired.No apparent harm to the patient.

Manufacturer Narrative

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 that the catheter was ballooning was confirmed and the damage appears to be associated with use of the device.The implicated product was a broviac 4.2fr s/l catheter; however, the product that was returned for investigation was a repair segment for a broviac 4.2 fr s/l catheter (p/n 0601610).The tubing extended 5.2cm from the distal end of the clamping oversleeve.Evidence of use was observed on the returned sample.The printing on the clamping oversleeve was partially worn.Residue was observed within the crevices of the clamp.A tacky residue, which could be from a dressing, was observed on the luer adaptor, clamping oversleeve, and section of tubing distal to the clamping oversleeve.A tactual investigation revealed elastic weakness in the tubing distal to the clamping oversleeve.A functional testing revealed that the lumen was patent to infusion; however, when pressurized with water, the catheter tubing bulged and ballooned just distal to the clamping oversleeve.No leaks were observed.The ballooning of the catheter tubing was either caused by overpressurization or from stretching the catheter to the point of weakening the catheter material, which would allow the tubing to balloon under a relatively lower pressure.The damage to the catheter appeared to have occurred during use.

Event Description

It was reported by the facility that the patient was brought to the clinic on (b)(6) 2017 by his parents for repair of a line that was noted to be ballooning at home.The line was repaired.No apparent harm to the patient.

• Brand Name: 215 REPAIR 0.7MM-WHITE
• 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 SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6745389
• MDR Text Key: 81249856
• Report Number: 3006260740-2017-01130
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051807
• UDI-Public: (01)00801741051807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830256
• 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,Followup
• Report Date: 09/20/2017

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 Expiration Date: 12/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 0601610
• Device Lot Number: HUAW_2254(INCORRECT)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 07/26/2017
• Supplement Dates Manufacturer Received: 08/07/2017
• Supplement Dates FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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: 15 MO