MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV 4F RADIOLOGY BT DL (WITH HYDRO-GLIDE INSERTION STYLET); 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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/29/2021
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 refs0020 showed two other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same complainant.
Event or Problem Description
It was reported "patient came to clinic and ¿was bleeding from the picc¿.Per parent-red lumen not working.On assessment- the red lumen is cracked at the connection of the tubing to the red hub.The line was open, but able to secure with clamp above the break.Patient¿s mom noted the red.It was stated that the line was removed and replaced.".
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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of damage extension leg tubing is confirmed; however, the exact cause is unknown.One 4 fr dual lumen powerpicc sv catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.A large split was observed in the extension leg tubing of the red lumen just within the distal end of the luer hub.A microscopic observation revealed the fracture surfaces of the split were flat but rough and exhibited cracks/fissures and beach marks, which are suggestive of material fatigue.However, the exact cause of the split observed in the returned sample is unknown.Possible contributing factors include excessive pulling, twisting, and manipulation of the luer connector hub and/or extension leg.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "patient came to clinic and ¿was bleeding from the picc¿.Per parent-red lumen not working.On assessment- the red lumen is cracked at the connection of the tubing to the red hub.The line was open, but able to secure with clamp above the break.Patient¿s mom noted the red.It was stated that the line was removed and replaced.".

• Brand Name: POWERPICC SV 4F RADIOLOGY BT DL (WITH HYDRO-GLIDE INSERTION STYLET)
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12862762
• Report Number: 3006260740-2021-04987
• Device Sequence Number: 17231505
• Product Code: LJS
• UDI-Device Identifier: 00801741027864
• UDI-Public: (01)00801741027864
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 01/26/2022

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 Model Number: N/A
• Device Catalogue Number: 3274355
• Device Lot Number: REFS0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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 Age: 5 YR
• Patient Sex: Female