MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER WITH TIP LOCATION SYSTEM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of redy2960 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via (b)(4): "patient with powerpicc solo (reference# 9194108.Lot# redy2960) placed on (b)(6) 2020 and removed on (b)(6) 2020 asking for powerpicc solo catheter material content stating she had a reaction to the catheter.Caller states her doctor removed it and there was a 3" fibrin clot on the end of the catheter her doctor said may be related to allergy.Caller states she has lyme's disease and has increased fibrin activity.Caller states she does not think there was a device problem but that she reacted to the device material.Caller also asking in general for material content that bard/bd ports are made of stating she asked her doctor and they said to call manufacturer." (b)(4) response: "informed caller powerpicc solo is a polyurethane catheter with silicone valves.Informed that in general, bard/bd ports are titanium or plastic with silicone septums and either a polyurethane catheter or a silicone (groshong) catheter.Explained that her healthcare provider can also call and provided my name per request." additional information received 12/09/2020: "as a patient i do not know the type of attachment product that was used.I do know that when changed it clicked in place on both sides.The statement provided by your firm is a bit off.I was allergic to the polyvinyl portion of the picc line and my skin became very irritated and itchy.Not just at the picc line site but it grew across my body.I needed to get prednisone and an antihistamine to control the itching.Initially it was thought i was allergic to the rocephrin it was delivering.After testing me for a reaction to the rocephrin it was found it wasn't the drug but the picc line itself that was the problem.The dr.Did not say the clot was the reason for the allergic reaction itself.The clot was just an extra "surprize" when the line was taken out.I'm sorry the product was taken out and thrown away by the dr." this report addresses the clot at the end of the picc line.

• Brand Name: POWERPICC SOLO CATHETER WITH TIP LOCATION SYSTEM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11110699
• Report Number: 3006260740-2020-21154
• Device Sequence Number: 3878905
• Product Code: LJS
• UDI-Device Identifier: 00801741028595
• UDI-Public: (01)00801741028595
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2020

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 Model Number: N/A
• Device Catalogue Number: 9194108
• Device Lot Number: REDY2960
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/04/2021
• 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: Other
• Patient Age: 64 YR
• Patient Weight: 85