MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER 6 F DL, IR; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
Per sales rep, the facility reported that at the end of the procedure, during flushing, the hub began to leak.It was stated that the hub was cracked.The picc was removed and replaced.There was no patient harm reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 that the catheter caused or contributed to the reported leak was unconfirmed since the problem could not be replicated.One 6fr d/l powerpicc was returned for investigation.The d/l tubing had been trimmed to length at the 50cm depth mark.A microscopic examination of the connectors revealed nothing remarkable.A functional test revealed that the lumens were patent to infusion.The powerpicc was repeatedly pressurized with water, but no leaks were detected in any part of the catheter.Since no leaks were observed in the returned device, the complaint that the returned powerpicc caused or contributed to the reported event was unconfirmed.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
Per sales rep, the facility reported that at the end of the procedure, during flushing, the hub began to leak.It was stated that the hub was cracked.The picc was removed and replaced.There was no patient harm reported.

• Brand Name: POWERPICC CATHETER 6 F DL, IR
• 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: 6982062
• Report Number: 3006260740-2017-01907
• Device Sequence Number: 519067
• Product Code: LJS
• UDI-Device Identifier: 00801741136528
• UDI-Public: (01)00801741136528
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K050931
• 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): 11/29/2017

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 Model Number: N/A
• Device Catalogue Number: CK000649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1