MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA 5F TL MAX BARRIER PLUS KIT W/BIOPATCH, PROBE COVER, & BELDAR N; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recq2189 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the introducer was resistance to snapping and when it did, one of the handles snapped of completely.The rn used hemostat to peel it away.The device was placed successfully.

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 of a broken introducer sheath tab is confirmed and appears to be manufacturing related.One 5 fr microez micro-introducer was returned.Use residue was observed on the returned sample.The tabs had been split and the grey sheath was peeled.One side of the tabs had the grey sheath detached from the tab.The tab was also broken from the section below the handle.Microscopic observation of the fractured surface of the revealed it to be uneven.The manufacturing facility was notified of this event.A lot history review (lhr) of recq2189 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the introducer was resistance to snapping and when it did, one of the handles snapped of completely.The rn used hemostat to peel it away.The device was placed successfully.

• Brand Name: POWERPICC PROVENA 5F TL MAX BARRIER PLUS KIT W/BIOPATCH, PROBE COVER, & BELDAR N
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8189495
• MDR Text Key: 131177766
• Report Number: 3006260740-2018-03702
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741155178
• UDI-Public: (01)00801741155178
• Combination Product (y/n): N
• PMA/PMN Number: K053501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

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: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: S1385108D5
• Device Lot Number: RECQ2189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1