MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F W/MICROINTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that there was a 5french dl3cg ppicc placed on a patient earlier in the week and they got a call from one of the bedside nurses saying while they were turning the patient it ¿broke¿.Sandy describes it that it looks like it ripped at the hub on the extension set.The bedside team didn¿t save it when they pulled it.Additional information received on 29 august 2023: the event did not involve an urgent/life threatening medical situation.There were no pieces retained in the 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 manufacturer has received the sample and will evaluate.Results are expected soon.
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 a broken extension leg is confirmed; however, the exact cause is unknown.One photograph of a dual lumen powerpicc was returned for evaluation.An initial visual observation of the photograph showed the extension legs of a powerpicc catheter inserted into a patient.The luer hub of one of the extension legs was observed to be broken off and missing.The break in the extension leg tubing appeared to be rough, but somewhat straight; however, no further details of the break could be discerned from the returned photograph.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer that there was a 5french dl3cg ppicc placed on a patient earlier in the week and they got a call from one of the bedside nurses saying while they were turning the patient it ¿broke¿.Nurse describes it that it looks like it ripped at the hub on the extension set.The bedside team didn¿t save it when they pulled it.Additional information received on 29 august 2023: the event did not involve an urgent/life threatening medical situation.There were no pieces retained in the patient.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F W/MICROINTRODUCER
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17699513
• Report Number: 3006260740-2023-03958
• Device Sequence Number: 20694465
• Product Code: LJS
• UDI-Device Identifier: 00801741034558
• UDI-Public: (01)00801741034558
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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 Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 1275108D
• Device Lot Number: REHP3729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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: Other
• Patient Sex: Unknown