MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5 F POLYURETHANE CATHETER NURSING BASIC TRAY WITH MICROINTRODUCER (55C; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of reax1714 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after 8 months of use, the picc catheter presented a fracture / tiny hole with extravasation of the serum therapy near the insertion.It was possible to visualize due to the detachment of the dressing.Because of this, x-ray contrast was requested, confirming this leak and soon after the examination the catheter was removed from the patient.
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 that the catheter caused or contributed to the reported leak was unconfirmed since no leak could be replicated within the device.One 5fr single lumen powerpicc was returned for investigation.The catheter exhibited evidence of use.The printing on the extension leg and molded wing was partially worn.Impressions from grasping instruments (e.G.Forceps) were observed in the purple connector.The tubing had been trimmed to length and extended to the 40cm depth mark.Residue that is consistent with the tacky substance that remains after tape or a dressing is removed was observed on the extension leg and molded wing.The clamp was closed over the extension leg.Both a functional test and a microscopic examination revealed no breaches in any part of the catheter.It was reported that the picc presented a fracture/hole after 8 months of use.Since the catheter had been used without any problem for 8 months, there is no indication that the manufacturing process caused the reported problem.Since no leaks could be replicated in the device, the complaint was unconfirmed.A lot history review (lhr) of reax1714 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after 8 months of use, the picc catheter presented a fracture / tiny hole with extravasation of the serum therapy near the insertion.It was possible to visualize due to the detachment of the dressing.Because of this, x-ray contrast was requested, confirming this leak and soon after the examination the catheter was removed from the patient.

• Brand Name: POWERPICC 5 F POLYURETHANE CATHETER NURSING BASIC TRAY WITH MICROINTRODUCER (55C
• 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: 8142202
• Report Number: 3006260740-2018-03500
• Device Sequence Number: 19304858
• Product Code: LJS
• UDI-Device Identifier: 00801741027666
• UDI-Public: (01)00801741027666
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K033389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 3175118
• Device Lot Number: REAX1714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR