MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redv3533 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that there was resistance threading it around the axillary and subclavian area and the wire seemed like it was flipping.The employee took out the wire completely from the catheter and noticed it was not fully intact.A new kit was opened and the wire was inserted through the catheter with no issues.1/28/2019-additional information received stated, "difficulty threading the picc and noticed wire was not fully intact.Replaced with new sterile picc and it threading okay per procedure notes.".
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 review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken stylet is not confirmed; however, a kink was present in the polyimide tubing.One 3cg stylet with t-lock assembly was returned for investigation.The stylet was observed to be intact; however, a kink in the polyimide tubing was present 2.6 cm from the distal end.Microscopic observation revealed no fractures in the tubing.No additional kinks in the tubing were present.Based on the condition of the returned sample, possible contributing factors include advancement against resistance and damage during handling.The exact source and cause of the force leading to the kinking of the stylet could not be determined; therefore, the complaint is confirmed, cause unknown.A lot history review (lhr) of redv3533 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that there was resistance threading it around the axillary and subclavian area and the wire seemed like it was flipping.The employee took out the wire completely from the catheter and noticed it was not fully intact.A new kit was opened and the wire was inserted through the catheter with no issues.(b)(6) 2019, additional information received stated, "difficulty threading the picc and noticed wire was not fully intact.Replaced with new sterile picc and it threading okay per procedure notes.".

• Brand Name: POWERPICC 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: 9700902
• Report Number: 3006260740-2020-00494
• Device Sequence Number: 1877763
• Product Code: LJS
• UDI-Device Identifier: 00801741142604
• UDI-Public: (01)00801741142604
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CK000775
• Device Lot Number: REDV3533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 83