MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 18G X 8 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken catheter is confirmed; however, the exact cause is unknown.One photograph of a powerglide pro catheter segment was returned for evaluation.An initial visual observation of the photograph showed blood residue within the catheter segment.The distal end of the catheter was observed to be curved and at least two bends were observed in the catheter shaft.The proximal end of the catheter segment appeared to be somewhat uneven; however, details of this section could not be discerned from the returned sample.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported "patient was sent to surgery this morning (7/28) as there was a powerglide on (7/25) that "broke off" into patient and they needed to get it out.Device was thrown away but catheter that was found in arm was sent to pathology after surgery." picc was placed in right upper arm and secured with statlock.

• Brand Name: FULL KIT 18G X 8 CM WITH BIOPATCH AND PROBE COVER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10435991
• Report Number: 3006260740-2020-03013
• Device Sequence Number: 4129021
• Product Code: FOZ
• UDI-Device Identifier: 00801741140655
• UDI-Public: (01)00801741140655
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F318088PT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention