MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER FULL KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Material Perforation (2205)

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

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 a "a stiffer guidewire that was perforating and kicking the catheter" was inconclusive because the originally implicated device(s) was not returned for evaluation. The product returned for evaluation was one 18ga x 10cm powerglide midline catheter assembly. The sample was received in its original sealed packaging. Following opening of the sealed kit, inspection of the powerglide assembly was unremarkable. Attempts to advance and retract the guidewire were successful and unremarkable. Advancement of the catheter and deployment of the safety mechanism was successful and unremarkable. Tactile inspection of the advanced guidewire revealed that it felt similar in rigidity to that of a similar non-complainant device. Microscopic inspection of the guidewire carrier coupler was unremarkable. No deficiencies were discovered during evaluation of the returned sample; however, the sealed nature of the returned packaging indicated that the returned device was not the originally implicated device. Consequently this complaint is inconclusive at this time. A lot history review (lhr) of rebt0432 showed three other similar product complaint(s) from this lot number. The complaints for this lot number (rebt0432) have been reported from the same facility.

Event Description

It was reported that the nurse used a powerglide catheter and stated that the guidewire was stiffer than normal and perforated and "kicked" the catheter. No patient hard was reported. This report addresses the first of four devices used.

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 rebt0432 showed three other similar product complaint(s) from this lot number. The complaints for this lot number (rebt0432) have been reported from the same facility.

Event Description

It was reported that the nurse used a powerglide catheter and stated that the guidewire was stiffer than normal and perforated and "kicked" the catheter. No patient hard was reported. This report addresses the first of four devices used.

• Brand Name: POWERGLIDE MIDLINE CATHETER FULL KIT
• 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: 7220684
• MDR Text Key: 194237850
• Report Number: 3006260740-2018-00052
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: M118101
• Device Lot Number: REBT0432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial