MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER 6F FULL TRAY (TRIPLE-LUMEN)(WITH MICROINTRODUCER) (WITH LIDOC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recw0994 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a 6fr picc "fractured" while in the patient.Necessitating the removal of the free floating remainder (31cm) by interventional radiology.
Event or Problem Description
It was reported that a 6fr picc "fractured" while in the patient.Necessitating the removal of the free floating remainder (31cm) by interventional radiology.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 break in the catheter was confirmed but the exact cause was unknown.One 6fr triple-lumen powerpicc was returned for investigation.Evidence of use was observed on the catheter.It was reported that the 6fr triple-lumen powerpicc was placed on (b)(6) 2018.Residue from a dressing was observed on the extension legs.Injection caps remained attached to each connector.What appeared to be biological residue (e.G.Blood) was observed on the external surface of the catheter.The catheter was received in two segments.The triple lumen tubing extended 1.8cm from the distal end of the trifurcation and a break was observed between the 0 and 1 cm depth markers.The break site was microscopically examined.The adjoining surfaces of the catheter were rough, uneven, jagged, and granular.Abrasions and impressions were visible on the external surface of the tubing at the break site, which indicate that the catheter was most likely affected by an external source.It appeared that the catheter was damaged during use and it is possible that the observed impressions were from a securement device or suture that was placed around the catheter; however, the exact cause of the impressions is unknown, but they appear to be associated with the break in the catheter.No other events were reported from the implicated lot.The reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of recw0994 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC CATHETER 6F FULL TRAY (TRIPLE-LUMEN)(WITH MICROINTRODUCER) (WITH LIDOC
• 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: 8242346
• Report Number: 3006260740-2019-00012
• Device Sequence Number: 16736740
• Product Code: LJS
• UDI-Device Identifier: 00801741028229
• UDI-Public: (01)00801741028229
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3386108
• Device Lot Number: RECW0994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/23/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention