MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER, 4F SL, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	CK000775A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
Event or Problem Description
Customer reported: our team inserted a bard 4fr single lumen picc in a patient.Unfortunately, the patient did suffer from an air embolism secondary to the picc line.The picc line was removed as the integrity of the line was in question as a result of the clinical outcome of this patient.
Event or Problem Description
Customer reported: our team inserted a bard 4fr single lumen picc in a patient.Unfortunately, the patient did suffer from an air embolism secondary to the picc line.The picc line was removed as the integrity of the line was in question as a result of the clinical outcome of this patient.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The complaint of air embolism secondary to the picc was inconclusive due to the sample condition.A series of photographs and a video of the implicated 4fr s/l powerpicc were returned for evaluation of this complaint.The catheter had been removed from the patient and was laid out on a wrap or cloth.The catheter contained evidence of use including worn print on the extension leg and molded bifurcation, curved shape memory near the 5cm and 25cm depth markings, and adhesive residue on the extension leg.No splits, cracks, or holes were visible in the catheter.The video was of a functional test of the catheter.A syringe was attached to the catheter luer adaptor and the distal end of the catheter was submerged in a container of liquid.Fluid was seen entering into the syringe barrel when the syringe plunger was retracted, indicating that the catheter aspirated fluid per design.No leaks of fluid were noted during the functional test.No air was seen entering into the syringe barrel during aspiration.As the submitted photographs and video did not contain enough information to confirm the event or identify a specific root cause, this complaint will be recorded as inconclusive at this time.If the physical sample is received at a later date, this investigation will be updated with the relevant information.The report of air embolism has been documented and included in complaint trending.This type of complaint will continue to be monitored as part of ongoing efforts to identify potential issues.Possible contributing factors for air embolism could include a leak at the connection to an auxiliary device or a leak/break in the catheter.H3 other text: evaluation findings are in section h11.

• Brand Name: POWERPICC CATHETER, 4F SL, 3CG
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16904582
• Report Number: 3006260740-2023-01805
• Device Sequence Number: 12467275
• Product Code: LJS
• UDI-Device Identifier: 00801741188060
• UDI-Public: (01)00801741188060
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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 Expiration Date: 01/31/2024
• Device Catalogue Number: CK000775A
• Device Lot Number: REGW2654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown