MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO FT TPS 5F MAXIMAL BARRIER TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	1295108FD
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported "issue with a solo valve breaking off of the line." additional information received 03/11/2021 it was reported double lumen picc inserted.Hub of one of the lumen came off during patient turning.Picc line removed due to malfunction.New picc line placed.
Event or Problem Description
It was reported "issue with a solo valve breaking off of the line." additional information received 03/11/2021 it was reported double lumen picc inserted.Hub of one of the lumen came off during patient turning.Picc line removed due to malfunction.New picc line placed.
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a detached solo connector was confirmed.One 5fr powerpicc solo ft was returned for investigation.The catheter exhibited evidence of use.The dual-lumen (d/l) tubing had been trimmed to length at the 43cm depth mark.The catheter was received with the statlock stabilization device attached to the molded wing.What appeared to be blood residue was visible within the extension legs.One of the solo connectors was missing.The catheter was received with only the red connector.The extension leg with the missing connector exhibited impressions from what are consistent with hemostats.The extension leg extended 9.5cm from the molded bifurcation.Necking or narrowing of the extension leg tubing was observed distal to the impressions in the tubing.The outside diameter of the tubing within the narrow region was below the minimum specification limit.The deformation of the tubing indicates that the extension leg was subject to tensile (pulling) forces.It was reported that the hub came off during patient turning.No damage associated with the manufacturing process was observed on the returned sample.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC SOLO FT TPS 5F MAXIMAL BARRIER TRAY
• 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: 11577373
• Report Number: 3006260740-2021-01019
• Device Sequence Number: 19698079
• Product Code: LJS
• UDI-Device Identifier: 00801741034626
• UDI-Public: (01)00801741034626
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 1295108FD
• Device Catalogue Number: 1295108FD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 06/03/2021
• 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