MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 5F TL MAX BARRIER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S1385108D1
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
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 reew2971 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "one of my picc rns discovered that a t-set that is part of our picc tray was defective and had a leak between the plastic tubing and the hard plastic t.Came from powerpicc provena ref# (b)(4).Lot#reew2971.Ex 2021-11-30." additional information received 01/11/2021: vascular access rn placed dl powerpicc provena ref# (b)(4) lot#reew2971 in patient and noticed there was leaking coming from the t set tubing.Picc was placed with difficulty.What type of catheter securement was utilized: statlock.Was there patient harm reported? no.
Event or Problem Description
It was reported "one of my picc rns discovered that a t-set that is part of our picc tray was defective and had a leak between the plastic tubing and the hard plastic t.Came from powerpicc provena ref#s1385108d1.Lot#reew2971.Ex 2021-11-30." add info received 01/11/2021: vascular access rn placed dl powerpicc provena ref#s1385108d1 lot#reew2971 in patient and noticed there was leaking coming from the t set tubing.Picc was placed with difficulty.What type of catheter securement was utilized: statlock.Was there patient harm reported?: no.
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 a leaking t-lock assembly was confirmed and the cause appeared to be manufacturing-related.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusions; however, a leak was observed emanating from the joint between the extension tubing and the luer distal luer adapter.Microscopic inspection of the sample revealed a void in the bond between the extension tubing and the distal luer, which appeared to correspond to the observed leak path.The void in the bond appeared to be the cause of the observed leakage.The appeared to have occurred during the device assembly process.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.

• Brand Name: POWERPICC PROVENA 5F TL MAX BARRIER
• 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
• MDR Report Key: 11251673
• Report Number: 3006260740-2021-00125
• Device Sequence Number: 4228639
• Product Code: LJS
• UDI-Device Identifier: 00801741154768
• UDI-Public: (01)00801741154768
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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: S1385108D1
• Device Catalogue Number: S1385108D1
• Device Lot Number: REEW2971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other