MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S1395108D5
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by healthcare professional "we had an issue with a picc today where one of my coworkers was setting up to place a triple lumen picc and when she was priming her line she noticed that she could not flush the white lumen.She disconnected and reconnected all possible connections and still could not flush the white lumen.We just started over with a new picc kit.We looked more closely and noticed there is a 3.5 cm wire looking object stuck in the lumen.".
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 an obstruction in the extension tubing is confirmed and appears to be manufacturing related.Three photos of a triple lumen powerpicc solo catheter were provided for evaluation.The first two images show the catheter extension legs.A solid rod appears to be present within the extension tubing of the white hub lumen.The rod appears to have a grey metallic color.The third image shows a closer view of the rod within the extension tubing.A paper ruler is being held besides the extension tubing.The metallic rod appears to measure 3.5 cm in length.Based on the location of the material, the material was likely introduced during the manufacturing process of the device; therefore, the complaint is confirmed.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 by healthcare professional "we had an issue with a picc today where one of my coworkers was setting up to place a triple lumen picc and when she was priming her line she noticed that she could not flush the white lumen.She disconnected and reconnected all possible connections and still could not flush the white lumen.We just started over with a new picc kit.We looked more closely and noticed there is a 3.5 cm wire looking object stuck in the lumen.".

• Brand Name: POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER
• 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: 12315732
• Report Number: 3006260740-2021-03270
• Device Sequence Number: 4447895
• Product Code: LJS
• UDI-Device Identifier: 00801741155222
• UDI-Public: (01)00801741155222
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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: S1395108D5
• Device Catalogue Number: S1395108D5
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/30/2021
• 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