MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	1174108
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/30/2018
Type of Reportable Event	Serious Injury
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 device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rect1831 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
Per email: received a product complaint pertaining to the power picc catheter with sherlock 3cg tip positioning system stylet.The stylet tip broke off of the stylet.It was dislodged into the patient¿s arm.No other details provided.
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 frayed 3cg stylet is confirmed.One 4 fr powerpicc catheter was returned with a 3cg stylet.The stylet was observed to be missing the distal segment which was not returned.Four kinks were observed at the proximal end of the stylet.The polyimide tubing extended approximately 4.7 cm from the broken distal end.A label sticker with ref: 1174108 and lot: rect1831 was returned.Microscopic observation of the distal tip of the polyimide tubing revealed a break between the tubing and the core wire.The tubing was observed to have multiple kinks at the magnet locations.The break surface of the tubing was uneven and showed evidence of slight compression.A section of the polyimide tubing was cut and the wall thickness was found to be within specification.It was stated that the picc experienced resistance during insertion and retraction of the catheter which may have contributed to the kinking and fraying of the stylet.Since the returned stylet was observed to be frayed, the complaint is confirmed.A lot history review (lhr) of rect1831 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per email: received a product complaint pertaining to the power picc catheter with sherlock 3cg tip positioning system stylet.The stylet tip broke off of the stylet.It was dislodged into the patient¿s arm.No other details provided.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F FULL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8092586
• Report Number: 3006260740-2018-03325
• Device Sequence Number: 11461161
• Product Code: LJS
• UDI-Device Identifier: 00801741034442
• UDI-Public: (01)00801741034442
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1174108
• Device Catalogue Number: 1174108
• Device Lot Number: RECT1831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention