MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PPICC SOLO; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	CK000663A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the guidewire kinked during insertion.No patient harm was reported.
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 kink in the stylet was confirmed, but the exact cause was unknown.One 3cg stylet was returned for investigation.The powerpicc was not returned with the stylet.A kink was observed in the polyimide tubing (distal end of stylet) 3.1cm from the distal tip of the stylet.The polyimide tubing, magnets, and core wire at the distal end of the stylet were intact.The polyimide tubing, magnets, and core wire at the distal end of the stylet were intact.A microscopic examination of the stylet confirmed that the distal end of the stylet was complete.It was reported that the kink was observed after it was removed from the picc.It is possible that the stylet was damaged during use.It may have inadvertently kinked during preparation for use or insertion of the powerpicc solo.It was reported that no difficulty or resistance was noted upon removal of the stylet.Complications, if any, during preparation or removal are unknown.The product ifu states, ¿ensure that the stylet tip does not extend beyond the trimmed end of the catheter.Extension of the stylet tip beyond the catheter end, combined with kinking and excessive forces, may result in vessel damage, stylet damage, difficult removal, stylet tip separation, potential embolism and risk of patient injury.¿ 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 that the guidewire kinked during insertion.No patient harm was reported.

• Brand Name: DOT PPICC SOLO
• 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: 7428770
• Report Number: 3006260740-2018-00692
• Device Sequence Number: 679592
• Product Code: LJS
• UDI-Device Identifier: 00801741134821
• UDI-Public: (01)00801741134821
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

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 Catalogue Number: CK000663A
• Device Lot Number: REBY0373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1