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 Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of safety mechanism failure was confirmed; however, the root cause was not identified.The product returned for evaluation was one 18ga power glide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter had been advanced and was not returned.The catheter advancement wings were detached from the assembly, and the safety mechanism outer housing was still attached to the wings.The remainder of the safety mechanism was not returned for evaluation.Microscopic inspection of the safety mechanism housing revealed it to appear properly formed.Stress fracturing was observed near one of the securement features.While the safety mechanism was observed to have become detached from the needle shaft, inspection of the returned safety housing was insufficient to identify the cause of that detachment, and the remaining safety mechanism components were not returned for evaluation.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.A lot history review (lhr) of redn3382 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported nurse inserted a power glide in right basilic vein, deployed guidewire and removed power glide handle.At this time i noticed that the needle was not sharp and the guidewire was intact.The green winged catheter advancer was found to have the top half of the ¿sharp¿ housing and the bottom half was still in the handle.The two halves separated and there was no way to ¿sharp¿ the needle.No harm done to the patient.7/11/2019 - returned sample shows a defective safety mechanism.

• 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 8854957
• MDR Text Key: 153798261
• Report Number: 3006260740-2019-02285
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140662
• UDI-Public: (01)00801741140662
• 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: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F318108PT
• Device Catalogue Number: F318108PT
• Device Lot Number: REDN3382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• 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