MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5FR TL POWERPICC CATHETER WITH 3CG STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redq3997 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported that the triple lumen 5 french with 3cg tps stylet power picc was placed on (b)(6) 2020, in an icu patient.It was stated to be leaking during flushing of the power injectable lumen, beneath the securacath.
Event or Problem Description
It was reported that the triple lumen 5 french with 3cg tps stylet power picc was placed on (b)(6) 2020, in an icu patient.It was stated to be leaking during flushing of the power injectable lumen, beneath the securacath.
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a leak was inconclusive, since the original sample was not returned for investigation.Two unopened kits from the implicated lot were returned for investigation.The components within the kits exhibited no damage or defects.The catheters were flushed and pressurized with water, but no leaks were observed in any part of the catheter.The wall thickness of each unused sample was within specification.It was reported that the leak was observed during infusion of the power injectable lumen.The leak was reportedly located beneath the non-vad securement device, which may have been a contributing factor in the reported event; however, since the affected sample was not returned for investigation, the exact cause of the damage could not be determined.A lot history review (lhr) of redq3997 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.

• Brand Name: 5FR TL POWERPICC CATHETER WITH 3CG 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: 9837730
• Report Number: 3006260740-2020-00860
• Device Sequence Number: 13638354
• Product Code: LJS
• UDI-Device Identifier: 00801741034640
• UDI-Public: (01)00801741034640
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 1385108Q
• Device Lot Number: REDQ3997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 63