MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA SOLO 5F TL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/09/2020
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 reeq1047 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported prior to placing the picc line, health professional noted that the grey port was split on the side and was leaking fluid.
Event or Problem Description
It was reported prior to placing the picc line, health professional noted that the grey port was split on the side and was leaking fluid.
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 damaged grey luer adapter was confirmed; however, the root cause was not identified.The product returned for evaluation was one 5fr t/l powerpicc solo catheter.The sample appeared free of obvious usage residues and an ecg stylet was inlaid through the red-luered lumen.Pieces were broken off of the grey leur at the orifice.The break sites appeared irregular.Microscopic inspection of the break sites revealed dully granular fracture surfaces.No mechanical damage or discoloration were observed in the vicinity of the breaks.The fracture features were consistent with brittle material failure.The lack of use residues, deformation and discoloration indicated the breakage was not caused by device misuse or manipulation.It appeared that environmental factors and manufacturing processes such as the molding process may have contributed.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.Reynosa evaluation: complaint due to ¿grey port was split on the side and was leaking fluid¿ was confirmed but the exact cause is unknown.According with the photo evaluation performed at reynosa facility and gross visual, microscopic visual performed at vad lab the following was concluded: a closer view of the grey luer hub showed an uneven deformation on the thread.A slight longitudinal break or indentation was found to be present.The damage surface appeared to be granular.Usage residue was observed within the orifice of the luer hub.Also, no seal transfer material was present on the luer hub surface.Damage during the manufacturing process may be a potential root cause/contributor to the observed grey luer hub damage.However, no findings from the dhr review indicated a manufacturing/processing related event.Possible contributions factors include: risks of damage during packaging, storage conditions, handling or use, etc.Therefore, as the definitive root cause of this damage could not be determined the cause of this condition remains unknown.

• Brand Name: POWERPICC PROVENA SOLO 5F TL 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10620756
• Report Number: 3006260740-2020-03435
• Device Sequence Number: 16951934
• Product Code: LJS
• UDI-Device Identifier: 00801741188831
• UDI-Public: (01)00801741188831
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: CK000886
• Device Lot Number: REEQ1047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1