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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
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 redp1360 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter was not flushing, the line was pulled and a crimp/kink was noted in the catheter roughly 3-4cm from tip.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kink in the catheter is inconclusive due to poor sample condition.One 5 fr powerpicc tl catheters and a note with lot: redp1360 was returned for investigation.The note also contained the date ¿6/11¿ and ¿line in place 10 days¿.The catheter extended up to the 38 cm depth marker.Use residue was present throughout the device.Microscopic observation of the outer catheter surface did not reveal clear evidence of a kinked section of the catheter at the alleged location.The sample was flushed with water using a 12 ml syringe and all three lumens were patent to infusion.The catheter was cut at the 34 cm depth marker and the catheter wall thickness was measured.The catheter was found to be within specification.The catheter kink may have relaxed to its normal position after removal from use.Since the kink was not observed on the returned sample and no issues were observed with the measured dimensions, the complaint is inconclusive.
Event or Problem Description
It was reported that the catheter was not flushing, the line was pulled and a crimp/kink was noted in the catheter roughly 3-4cm from tip.

• Brand Name: POWERPICC PROVENA 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: 8800376
• Report Number: 3006260740-2019-01992
• Device Sequence Number: 18912270
• Product Code: LJS
• UDI-Device Identifier: 00801741112720
• UDI-Public: (01)00801741112720
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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 Model Number: N/A
• Device Catalogue Number: S1385108D
• Device Lot Number: REDP1360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1