MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER W/ SHERLOCK 3CG 4F FULL TRAY; 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reex1081 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Hold for ce 10.25.21 it was reported via ms&s "nurse states she has a patient with a 4fr sl powerpicc who she thinks has damaged the catheter intentionally.The hole is on the distal end of the plastic winged portion of the catheter between the wings and graduation mark "0".The hole appears to be circumferential along the back side of the catheter.Could the catheter have "blown out" from too much pressure being injected into the picc line? what is the max psi?" ms&s response "informed caller that per the powerpicc ifu, "exceeding the maximum flow rate of 5 ml/sec, or the maximum pressure of power injectors of 300 psi, may result in catheter failure and/or catheter tip displacement".We do not have information on where the catheter would be damaged if the psi exceeded the recommendations of the ifu.Please note a fractured picc line can lead to blood loss or other complications.The picc line will need to be replaced for use and ensure the safety of the patient".
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 catheter was confirmed.The product returned for evaluation was one 4fr s/l powerpicc catheter.Usage residues were observed throughout the sample.Curved shape memory was observed along the length of the catheter.A partially circumferential split was observed just distal of the molded joint.Microscopic inspection of the split revealed sharply defined, glossy fracture surfaces.Multiple additional superficial splits were observed in the vicinity of the split.The fracture features were consistent with damage between the catheter shaft and a traumatic metallic instrument(s).These observations appeared consistent with the event description, which indicated ¿nurse states she has a patient with a 4fr sl powerpicc 1174108 who she thinks has damaged the catheter intentionally.¿ h3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported via ms&s "nurse states she has a patient with a 4fr sl powerpicc who she thinks has damaged the catheter intentionally.The hole is on the distal end of the plastic winged portion of the catheter between the wings and graduation mark "0".The hole appears to be circumferential along the back side of the catheter.Could the catheter have "blown out" from too much pressure being injected into the picc line? what is the max psi?" ms&s response "informed caller that per the powerpicc ifu, "exceeding the maximum flow rate of 5 ml/sec, or the maximum pressure of power injectors of 300 psi, may result in catheter failure and/or catheter tip displacement".We do not have information on where the catheter would be damaged if the psi exceeded the recommendations of the ifu.Please note a fractured picc line can lead to blood loss or other complications.The picc line will need to be replaced for use and ensure the safety of the patient".

• Brand Name: POWERPICC CATHETER W/ SHERLOCK 3CG 4F FULL 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
• 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: 12686946
• Report Number: 3006260740-2021-04510
• Device Sequence Number: 3855801
• Product Code: LJS
• UDI-Device Identifier: 00801741034442
• UDI-Public: (01)00801741034442
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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: N/A
• Device Catalogue Number: 1174108
• Device Lot Number: REEX1081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 10/24/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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: 20 YR
• Patient Sex: Female
• Patient Weight: 59 KG