MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Material Puncture/Hole (1504); Difficult to Remove (1528); Material Separation (1562); Physical Resistance (2578)

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

Event Date 04/03/2018

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reby1136 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that during the insertion procedure the nurse was able to thread the guidewire with no resistance.It was stated she did meet resistance when she attempted to thread the catheter and so she decided to remove the entire device.Removal was difficult and after it was removed the nurse found that the guidewire had punctured the catheter and was ¿looped¿.The guidewire also separated from the housing.No patient injury was reported.

Manufacturer Narrative

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 the guidewire/catheter damage was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 18ga x 8cm powerglide pro midline catheter assembly.The sample was received with the safety mechanism engaged and the catheter detached.The distal segment of the guidewire was detached from the assembly and remained inlaid through the catheter.Microscopic inspection of the guidewire revealed the weld tip to be intact.Inspection of the break in the guidewire revealed a granular fracture surface.Inspection of the split in the catheter revealed a granular fracture surface.Deformation and discoloration were observed in the vicinity of the split.Inspection of the tip of the catheter exhibited deformation.The catheter split characteristics were consistent with tearing type damage which appeared to be caused by contact with the guidewire.It appeared that the guidewire became kinked within the catheter and that subsequent tensile (pulling) stress on the wire caused both the catheter perforation and the guidewire elongation and breakage.Such kinking can occur if the catheter is withdrawn back onto the wire following advancement and if the wire is reinserted into the catheter following removal.A lot history review (lhr) of reby1136 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that during the insertion procedure the nurse was able to thread the guidewire with no resistance.It was stated she did meet resistance when she attempted to thread the catheter and so she decided to remove the entire device.Removal was difficult and after it was removed the nurse found that the guidewire had punctured the catheter and was ¿looped¿.The guidewire also separated from the housing.No patient injury was reported.

• Brand Name: FULL KIT 20G X 8 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: 7466764
• MDR Text Key: 106717849
• Report Number: 3006260740-2018-00815
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140679
• UDI-Public: (01)00801741140679
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

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: F320088PT
• Device Lot Number: REBY1136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 05/02/2018
• Supplement Dates FDA Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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