MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) of refr0398 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via ms&s "caller requesting bd recommendations on clamping her dad's powerpicc (ref (b)(4), lot#refr0398).States the last agency nurse that changed her dad's picc dressing and needleless connectors did not clamp his powerpicc and now his line is clotted.She wants to now if the nurse actions caused his picc to be occluded because she now has to pay for cathflo to get it working again.They never had any issues for months until recently.Ms&s explained the powerpicc device is a non-valved picc.The clamps are safety features that help prevent air embolism and bleeding in case the needleless connector becomes disconnected from the line.We would recommend the lumens be clamped between each use following the guidelines of the needleless connectors on her dad's powerpicc.Explained some possible causes of his picc occlusion.Customer states she is not sure if his catheter is being flushed with saline and heparin as recommended.Explained to make sure the physician is aware of the occlusion and nursing staff is welcome to call for instructions and bd's recommendations for her dad's powerpicc device.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12903857
• Report Number: 3006260740-2021-05063
• Device Sequence Number: 4962429
• Product Code: LJS
• UDI-Device Identifier: 00801741110030
• UDI-Public: (01)00801741110030
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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: CK000513A
• Device Lot Number: REFR0398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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: Male