MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT POWERPICC,4SL,3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	CK000244
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional 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 break in the 3cg stylet was confirmed.One 3cg stylet was returned for investigation.A break in the polyimide tubing was observed 1.8 cm from the distal tip of the stylet.A microscopic examination of the adjoining ends of the stylet revealed a rough and uneven surface.The stylet wire exhibited evidence of use.The stylet wire had been partially retracted through the extension set, kinked at the proximal end of the septum, and taped to the extension set.The entire stylet was returned for investigation.Kinks were observed in the polyimide tubing both proximal and distal to the break site.A break in the core wire coincided with the break in the polyimide tubing.A magnet was missing from the distal end of the proximal polyimide tubing segment.The wall thickness of the polyimide tubing was within specification.It was reported that the stylet was bent when it was removed from the catheter.The wire tip broke off in the bag once it was set aside for investigation.A lot history review (lhr) of 18fbe856 showed no other similar product complaint(s) from this lot number.[(b)(4)].
Event or Problem Description
It was reported that there was a fractured guidewire.It was stated the wire was bent when it was taken out of the patient.The wire tip broke off in the bag once it was set aside for investigation.Patient anatomy was not difficult.Additional information rec'd via medwatch stated, "single lumen picc trimmed to 37 cm.Introduced to about 15 cm, then noted resistance and picc removed.When inspecting the stylet, it was fractured at 2 cm from the tip.".

• Brand Name: DOT POWERPICC,4SL,3CG
• Common Device Name: 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: 8121590
• Report Number: 3006260740-2018-03458
• Device Sequence Number: 11241089
• Product Code: LJS
• UDI-Device Identifier: 00801741043659
• UDI-Public: (01)00801741043659
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2018
• Report Date (Section F): 11/29/2018

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
• Operator of Device: Health Professional
• Device Model Number: CK000244
• Device Catalogue Number: CK000240
• Device Lot Number: 18FBE856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 42