MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refs0210 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "upon injecting saline into the powerpicc solo # 3194355 the patient had a severe allergic reaction upon injection of saline into the catheter, requiring medical intervention.We treated the allergic reaction with medication." it was also reported via ms&s "i have a doctor who just called with a patient having a severe reaction after flushing powerpicc he just placed.He prepped the patient with chlorhexidine, allowed it to dry while setting up his sterile tray.After placing the picc he used a syringe to pull back to confirm placement with blood return.He then proceeded to inject saline to flush the line and the patient started having the reaction with severe shortness of breath.Could he have injected chlorhexidine from the skin prep?" ms&s: response explained to the caller that i have seen the incorrect medicine get injected into the line and cause reactions.The reaction occurred after the injection of the suspected "saline".Provided the caller with material of construction for the powerpicc.Powerpicc solo is made of polyurethane catheter, silicone valve in hubs and does not contain any natural rubber latex.Informed the rep that the incident needed to be reported.".

• Brand Name: POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN)
• 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: 12627142
• Report Number: 3006260740-2021-04351
• Device Sequence Number: 16986603
• Product Code: LJS
• UDI-Device Identifier: 00801741027789
• UDI-Public: (01)00801741027789
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3194355
• Device Lot Number: REFSS210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/13/2021
• 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: Required Intervention