MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number F318108PT

Device Problems Positioning Failure (1158); Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)

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

Event Date 09/01/2018

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, trend 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 guidewire damage and difficult device removal was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 18ga x 10cm powerglide pro rt midline catheter assembly.Blood residue was observed on the sample.The catheter was advanced on the needle shaft and the safety mechanism was engaged over the needle bevel.The housing was disassembled.The distal end of the guidewire was detached and was received loose.The weld tip appeared intact.The catheter exhibited curved shape memory and the tip appeared to exhibit deformation.Microscopic inspection of the broken wire fragment confirmed that the weld tip was intact.Inspection of the break in the core wire revealed a granular fracture surface.The fracture exhibited a region of increased luster.Curved shape memory was observed in the vicinity of the break.Inspection of the needle bevel revealed abundant ridged and outward flaring deformation along the proximal edge.Inspection of the distal tip of the catheter confirmed deformation and discoloration.The edges of the tip curved inward.The region of increased luster in the core wire and the needle bevel damage were consistent with wire damage initiated by withdrawal against the needle bevel.The catheter damage was also consistent with guidewire withdrawal.The blood residue indicated that damage occurred during attempted device insertion.A lot history review (lhr) of resc1192 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the facility that the rn deployed wire with no resistance but could not fully deploy catheter.It was stated there was some movement forward of the ¿wings¿, but would not move it forward into the vein.The rn tried to pull back wire but was not able to do so.The entire device was removed from patient, but again it was stated the rn encountered resistance.It was reported that when removed it was noted the wire had punctured catheter.

• Brand Name: FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: 7936753
• MDR Text Key: 123067119
• Report Number: 3006260740-2018-02727
• Device Sequence Number: 0
• Product Code: FOZ
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F318108PT
• Device Catalogue Number: F318108PT
• Device Lot Number: RESC1192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2018
• 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