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

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported, there have been complaints from our team regarding the peel away sheath and not completely separating when it was supposed to.Most recently, the sheath would not separate at the orange aspect of the sheath.The proceduralist thought they were going to have to insert the introducer and remove both components completely.We would not recommend using scissors but it was described to me that the proceduralist felt they needed scissors in order to separate the components of the peel away sheath.This is how difficult it was to separate.There were delays during the procedure as a result.The patient had the sheath in longer than needed.No injury was reported to the patient or healthcare professional.No other information was provided.A specific number of affected devices or patients was not provided by the complainant.
Event or Problem Description
It was reported, there have been complaints from our team regarding the peel away sheath and not completely separating when it was supposed to.Most recently, the sheath would not separate at the orange aspect of the sheath.The proceduralist thought they were going to have to insert the introducer and remove both components completely.We would not recommend using scissors but it was described to me that the proceduralist felt they needed scissors in order to separate the components of the peel away sheath.This is how difficult it was to separate.There were delays during the procedure as a result.The patient had the sheath in longer than needed.No injury was reported to the patient or healthcare professional.No other information was provided.A specific number of affected devices or patients was not provided by the complainant.
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 difficulty separating the sheath was confirmed and was determined to be manufacturing related.The product returned for evaluation was a 4.5fr microintroducer sheath.Light use residue was observed on the sheath.The sheath was returned completely split in half.Microscopic inspection of the orange handle revealed excess material which was deformed.A thin ring of plastic was observed around the catheter channel.The excess material on the handle suggested an incomplete skiving process during device manufacture.This complaint will be forwarded to the manufacturing site for further evaluation.This complaint will be recorded for future trending and monitoring purposes.

• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19824534
• Report Number: 3006260740-2024-04001
• Device Sequence Number: 8679473
• Product Code: LJS
• UDI-Device Identifier: 00801741188060
• UDI-Public: (01)00801741188060(11)240507(17)250831(10)REJQ0807
• 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): 10/28/2024

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: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: CK000775A
• Device Lot Number: REJQ0807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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