MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 FR SL POWERPICC WITH TLS, MAXIMAL BARRIER PRECAUTION KIT; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	9174108D
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2017
Type of Reportable Event	Malfunction
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reaw0754 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales rep, the primary nurse at the facility stated the picc line was leaking at the hub tubing connection.It was reported that the rn noted air in the line when trying to draw blood.No patient injury was reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 leaking catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 4fr s/l powerpicc catheter.Usage residues were observed throughout sample.The extension tubing markings were completely worn.The catheter terminated at the 46 cm depth marking.Microscopic inspection of the distal end of the catheter revealed striations typical of a sharp instrument cut.A partially circumferential split was observed at the junction between the extension tubing and the luer hub.An attempt to infuse water through the sample using a 12 ml syringe revealed the sample to be patent; however, a leak was observed emanating from the site of the aforementioned split.During aspiration, primarily air was drawn into the syringe.Tactile inspection of the sample revealed tensile and torsional weakness in the vicinity of the split.Microscopic inspection of the split revealed sharply defined granular edges.The split surfaces exhibited beach marks.The split characteristics and mechanical weakness were typical of material failure due to repetitive stress.The location of the damage suggested that catheter securement, maintenance and access technique may have contributed.
Event or Problem Description
Per sales rep, the primary nurse at the facility stated the picc line was leaking at the hub tubing connection.It was reported that the rn noted air in the line when trying to draw blood.No patient injury was reported.

• Brand Name: 4 FR SL POWERPICC WITH TLS, MAXIMAL BARRIER PRECAUTION KIT
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6474185
• Report Number: 3006260740-2017-00380
• Device Sequence Number: 13716767
• Product Code: LJS
• UDI-Device Identifier: 00801741035555
• UDI-Public: (01)00801741035555(17)180331(10)REAW0754
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2017

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: 03/31/2018
• Device Catalogue Number: 9174108D
• Device Lot Number: REAW0754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 110