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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reen2502 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported yesterday the team was inserting a 3 fr single lumen picc for a 5 year old, at the end of the procedure when the guide wire was being removed from the catheter, it was noted that the guidewire was fractured approximately 5 cm from the tip and was dangling.The wire had been withdrawn and the catheter was trimmed prior to the procedure.The inserter is 100% certain that the guidewire was withdrawn well past the trim site.The insertion was uneventful, however the 3cg was not reading correctly and a chest x-ray was obtained.
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 broken stylet was confirmed but the exact cause remains unknown.One 3cg stylet was returned for evaluation.The stylet was returned coiled around itself.A complete break in the polyimide tubing was present approximately 4.8 cm from the distal end.The core wire was still intact.Microscopic observation of the distal tip of the stylet revealed it to be intact.The area near the fracture location was observed to be compressed which suggest the stylet likely kinked before the fracture.A slight bent in the polyimide tubing was observed approximately 2 cm from the fractured region.The polyimide tubing was cut near the break location in order to measure the wall thickness.The wall thickness was found to be within manufacturing specification.Based on the condition of the returned stylet, possible contributing factors include damage during handling, advancement against resistance, and patient anatomy.Since the stylet was observed to be fractured, the complaint is confirmed, cause unknown.A lot history review (lhr) of reen2502 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported yesterday the team was inserting a 3 fr single lumen picc for a 5 year old, at the end of the procedure when the guide wire was being removed from the catheter, it was noted that the guidewire was fractured approximately 5 cm from the tip and was dangling.The wire had been withdrawn and the catheter was trimmed prior to the procedure.The inserter is 100% certain that the guidewire was withdrawn well past the trim site.The insertion was uneventful, however the 3cg was not reading correctly and a chest x-ray was obtained.
Event or Problem Description
It was reported "yesterday the team was inserting a 3 fr single lumen picc for a 5 year old, at the end of the procedure when the guide wire was being removed from the catheter, it was noted that the guidewire was fractured approximately 5 cm from the tip and was dangling.The wire had been withdrawn and the catheter was trimmed prior to the procedure.The inserter is 100% certain that the guidewire was withdrawn well past the trim site.The insertion was uneventful, however the 3cg was not reading correctly and a chest x-ray was obtained." per additional information rcvd: the stylet was identified as partially fractured at the end of the insertion process when the stylet was removed from the catheter.The inserter reports with absolutely certainty that the stylet was withdrawn back well beyond the trim point when the catheter was trimmed for insertion.Insertion procedure went smoothly, no unexpected issues other than the 3cg reading was not responding as expected.3/15/2021 medwatch received stated- "after uneventful, successful placement of a picc (peripherally inserted central catheter), the stylet upon removal was noted to have a partial fracture, approximately 5cm from the tip.Thankfully, the fracture was not complete as the entire stylet was noted to be present.Concern expressed regarding implications if the fracture had been complete.".
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 broken stylet was confirmed but the exact cause remains unknown.One 3cg stylet was returned for evaluation.The stylet was returned coiled around itself.A complete break in the polyimide tubing was present approximately 4.8 cm from the distal end.The core wire was still intact.Microscopic observation of the distal tip of the stylet revealed it to be intact.The area near the fracture location was observed to be compressed which suggest the stylet likely kinked before the fracture.A slight bent in the polyimide tubing was observed approximately 2 cm from the fractured region.The polyimide tubing was cut near the break location in order to measure the wall thickness.The wall thickness was found to be within manufacturing specification.Based on the condition of the returned stylet, possible contributing factors include damage during handling, advancement against resistance, and patient anatomy.Since the stylet was observed to be fractured, the complaint is confirmed, cause unknown.A lot history review (lhr) of reen2502 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET (3F)
• 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: 10370935
• Report Number: 3006260740-2020-02776
• Device Sequence Number: 3094219
• Product Code: LJS
• UDI-Device Identifier: 00801741152580
• UDI-Public: (01)00801741152580
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2021

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: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: CK000821
• Device Lot Number: REEN2502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 09/14/2020; 03/15/2021
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 09/30/2020; 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Weight: 13