MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reen4692 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported a picc wire was noted to have a severe kink in it before it was inserted into the patient.The scenario was that the nurse loosened the leur lock and pulled the wire back prior to cutting the catheter to it's desired length.When she went to advance the wire back thru the catheter she noted a significant kink in the wire,almost to a fracture point.The kink is at approximately 3.5cm from the end of the wire.The nurse did not place the picc in the patient as we have had other issues in the past with the wires kinking and fracturing.The picc wasn't used on a patient and a new kit was opened for placement.
Event or Problem Description
It was reported a picc wire was noted to have a severe kink in it before it was inserted into the patient.The scenario was that the nurse loosened the leur lock and pulled the wire back prior to cutting the catheter to it's desired length.When she went to advance the wire back thru the catheter she noted a significant kink in the wire,almost to a fracture point.The kink is at approximately 3.5cm from the end of the wire.The nurse did not place the picc in the patient as we have had other issues in the past with the wires kinking and fracturing.The picc wasn't used on a patient and a new kit was opened for placement.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kinked stylet was confirmed but the exact cause remains unknown.One 3cg stylet was returned for evaluation.The stylet was returned coiled around itself.A kink in the polyimide tubing was present 3.6 cm from the distal end.Microscopic observation of the distal tip of the stylet revealed it to be intact.The kink was observed to be between two magnets within the polyimide tubing.Additional kinks were not observed.The polyimide tubing was cut near the kink location in order to measure the wall thickness.The wall thickness was found to be within manufacturing specification.A review of the manufacturing records did not reveal evidence to suggest a manufacturing related root cause contributed to the reported event.The event description indicates the kink was formed during readvancement of the of the stylet into the catheter.Damage during handling and advancement against resistance may have contributed to the formation of the kink; however, the exact cause remains unknown.A lot history review (lhr) of reen4692 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• 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: 10405216
• Report Number: 3006260740-2020-02931
• Device Sequence Number: 19581221
• Product Code: LJS
• UDI-Device Identifier: 00801741034626
• UDI-Public: (01)00801741034626
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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 Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 1295108FD
• Device Lot Number: REEN4692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1