MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY; 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	03/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when bedside rn was attempting to prepare patient to draw labs, infusion pump was stopped.After a few moments, bedside rn approached patient and noted blood leaking from picc line.Leak was noted to be above the purple hub at the tubing.Picc team rn was consulted.Picc team rn came to bedside, upon their assessment picc line was compromised.As a result tpn had to be stopped and patient required peripheral ivs to continue iv fluid replacement.Picc line needed to be removed and replaced.A piv was placed.
Event or Problem Description
It was reported that when bedside rn was attempting to prepare patient to draw labs, infusion pump was stopped.After a few moments, bedside rn approached patient and noted blood leaking from picc line.Leak was noted to be above the purple hub at the tubing.Picc team rn was consulted.Picc team rn came to bedside, upon their assessment picc line was compromised.As a result tpn had to be stopped and patient required peripheral ivs to continue iv fluid replacement.Picc line needed to be removed and replaced.A piv was placed.
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.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 5fr d/l powerpicc catheter.Usage residues were observed throughout the sample and needleless injection caps were attached to both luer adapters.A partially circumferential split was observed at the junction between the purple luer adapter and the extension tubing.Microscopic inspection of the split revealed granular fracture surface.The fracture surfaces exhibited beach marks.Material buckling was observed in the vicinity of the split.The fracture characteristics and material buckling were consistent with material fatigue failure due to repetitive torsional (twisting) stress.The location of the damage suggested that accessing/de-accessing of the purple luer adapter likely contributed.A lot history review (lhr) of recx3479 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY
• 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: 8505467
• Report Number: 3006260740-2019-00856
• Device Sequence Number: 2798102
• Product Code: LJS
• UDI-Device Identifier: 00801741035692
• UDI-Public: (01)00801741035692
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: 9275108D
• Device Lot Number: RECX3479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1