MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT W/BIOPATCH & PROBE COVER; 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	Pain (1994)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by tm ¿customer reports hole in picc just after 6cm mark.Rn that addressed the problem stated ¿the following day before i was asked to get labs from the picc, white and grew lumens were infusing, the red lumen was free, hard to flush and no blood returns.The nurse said she was going to call the doctor and would alteplase it.She said it clotted by then so was very hard to get the alteplase in.The nurse got a hold of clinician, and i went and flushed the white and grey lumens and had good blood returns, then flushed the red lumen and patient complained of burning with the flush.I had also completed a dressing change prior to flushing because patent was bleeding after the retraction.After flushing, dressing was full of fluid so doctor was contacted and they instructed to pull picc and place a piv.".
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refx5409 showed no other similar product complaint(s) from this lot number.
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 catheter was confirmed.The product returned for evaluation was one 5fr t/l powerpicc solo catheter.Usage residues were observed throughout the sample and needleless injection caps were attached to all three luer adapters.An attempt to infuse water through the sample using a 12ml syringe revealed the two small diameter lumens to be patent to infusion and aspiration with no observed leaks.Flushing the larger, power injectable lumen revealed a small leak at the 6cm depth marking.The catheter was fully occluded distal of the split.Microscopic inspection of the leak site revealed a small, irregular, longitudinally aligned split.The split exhibited granular fracture surface.Rough striations were visible in the fracture surface.Surface abrasions and longitudinally aligned impressions were observed in the vicinity of the split.The split features, material abrasion and impressions were consistent with damage caused by contact between the catheter shaft and a traumatic instrument(s) such as forceps or hemostats.It appeared that manipulation of the indwelling catheter resulted in damage/leakage.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by tm ¿customer reports hole in picc just after 6cm mark.Rn that addressed the problem stated ¿the following day before i was asked to get labs from the picc, white and grew lumens were infusing, the red lumen was free, hard to flush and no blood returns.The nurse said she was going to call the doctor and would alteplase it.She said it clotted by then so was very hard to get the alteplase in.The nurse got a hold of clinician, and i went and flushed the white and grey lumens and had good blood returns, then flushed the red lumen and patient complained of burning with the flush.I had also completed a dressing change prior to flushing because patent was bleeding after the retraction.After flushing, dressing was full of fluid so doctor was contacted and they instructed to pull picc and place a piv.".

• Brand Name: POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT W/BIOPATCH & 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15165441
• Report Number: 3006260740-2022-03047
• Device Sequence Number: 11912637
• Product Code: LJS
• UDI-Device Identifier: 00801741155123
• UDI-Public: (01)00801741155123
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: S1395108D4
• Device Lot Number: REFX5409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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