MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of regr2475 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer that there was air bubbles."this week while i was inserting a 5 french dl picc line, i noticed during the procedure i was getting air into my syringe every time i was checking for a blood return on the lumen with the wire (stylet wire).I removed the catheter from the transducer and flushed the line again, and noticed there was air bubbles coming from the clear extension.".
Event or Problem Description
It was reported by the customer that there was air bubbles."this week while i was inserting a 5 french dl picc line, i noticed during the procedure i was getting air into my syringe every time i was checking for a blood return on the lumen with the wire (stylet wire).I removed the catheter from the transducer and flushed the line again, and noticed there was air bubbles coming from the clear extension.".
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, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking t-lock is confirmed and was determined to be supplier related.One 5 fr dual lumen powerpicc solo ft catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.A 3cg stylet and t-lock were returned within the red lumen of the catheter.The red lumen of the catheter was flushed via the t-lock returned on the sample, and a leak was observed emanating from the junction of the hub and the tubing of the t-lock.A microscopic observation revealed a large gap in the adhesive bonding the tubing and the hard plastic hub of the t-lock.The t-lock hub was dissected, and a small gap was observed between the tubing and the hub material.The investigation was forwarded to the end-item manufacturing facility for further evaluation, and bd is working closely with the supplier to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15629314
• Report Number: 3006260740-2022-04044
• Device Sequence Number: 5983116
• Product Code: LJS
• UDI-Device Identifier: 00801741034626
• UDI-Public: (01)00801741034626
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/22/2022

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 Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 1295108FD
• Device Lot Number: REGR2475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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: Other
• Patient Sex: Unknown