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

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refx5370 showed fifteen other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "leaking at the hub." additional information received 03/31/2022 "there wasn t a crack in the hub that was causing a leak.It was a misalignment of the two halves of the hub that caused the needleless connector to not sit correctly.No matter how tight you tried to put the cap on, the device leaked when it was flushed.".
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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of leaking catheters was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was two 4fr s/l powerpicc catheters.Both samples exhibited use residues throughout.Attempts to infuse water through the samples using a 12ml syringe revealed both lumens to be patent to infusion; however, leaks were observed at the junctions between the luer adapters and the syringe.Microscopic inspection of the luer adapters revealed protrusions in the luer material within the orifices.The mold defects appeared to prevent firm attachment of the syringe.Longitudinally aligned scoring marks were observed within the orifice adjacent to the mold defect.The molding defects observed within the luer orifices prevented firm attachment with the syringe and resulted in leakage at the interfaces between the catheters and the syringe.Bd is working closely with manufacturing to prevent recurrence of the reported event.H3 other text: evaluation findings are in section h.11.
Event or Problem Description
It was reported "leaking at the hub." additional information received 03/31/2022 "there wasn't a crack in the hub that was causing a leak.It was a misalignment of the two halves of the hub that caused the needleless connector to not sit correctly.No matter how tight you tried to put the cap on, the device leaked when it was flushed.".

• Brand Name: POWERPICC 4F SL MAX BARRIER PLUS KIT
• 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: 14190392
• Report Number: 3006260740-2022-01458
• Device Sequence Number: 11864006
• Product Code: LJS
• UDI-Device Identifier: 00801741154737
• UDI-Public: (01)00801741154737
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 1174108D1
• Device Lot Number: REFX5370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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