MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM; 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 refx1855 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "5fr dual powerpicc leaking at purple hub." additional information received 04/04/2022: on day 3 of insertion (b)(6) 2022), rn noted leak on the connection of the hub and needleless connector over the purple lumen during infusion.Multiple needleless connectors were changed over the purple lumen but all were leaking.Red lumen did not have any issues.What type of catheter securement was utilized? securacath placement date: (b)(6) 2022, explant date: (b)(6) 2022, was the product used on a patient? yes was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome.No.
Additional Manufacturer Narrative
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 analysis, manufacture quality and production records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed, and the cause was manufacturing-related.The product returned for evaluation was one dot ppicc 5f dl 3cg catheter.Light usage residues were observed throughout the sample and a needleless injection cap was attached to the luer adapter.Microscopic inspection of the luer adapter revealed a protrusion in the luer material within the orifice.That material had the appearance of a mold defect which could result in inadequate sealing of the luer hub with a syringe.Bd is working closely with manufacturing to prevent recurrence of the reported event.
Event or Problem Description
It was reported "5fr dual powerpicc leaking at purple hub." additional information received 04/04/2022: on day 3 of insertion (3/24/2022), rn noted leak on the connection of the hub and needleless connector over the purple lumen during infusion.Multiple needleless connectors were changed over the purple lumen but all were leaking.Red lumen did not have any issues.What type of catheter securement was utilized? securacath.Placement date: 3/21/2022.Explant date: 3/25/2022.Was the product used on a patient? yes.Was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome.No.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14118266
• Report Number: 3006260740-2022-01323
• Device Sequence Number: 16717043
• Product Code: LJS
• UDI-Device Identifier: 00801741152573
• UDI-Public: (01)00801741152573
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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: CK000820
• Device Lot Number: REFX1855
• 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: 03/24/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 06/10/2022
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 98 KG