MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET MAXIMAL; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	CK000411
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rezf2307 showed one other similar product complaint(s) from this lot number.Both complaints for this lot number (rezf2307) have been reported from the same facility.No sample retained.
Event or Problem Description
Per sales representative, a nurse reported that when placing two piccs, the wire migrated backwards after the wire was "bent over the end and tightened down." nurse stated that she thought the wire knotted because only 4 cm was left inside the patient.At one point, the nurse reported that she was able to remove the wire which came out kinked and then re-inserted it up to the initial bend made when started.(b)(6) 2016 - per email received from nurse on (b)(6) 2016: rn reports that from the beginning, the patient told him that a past picc was a difficulty.The patient said it coiled up in his chest.Rn states there was no harm to patient.A new picc was placed by their team at "specials" under fluoroscopy.Rn also reported that getting the catheter to drop into the svc was a major problem.They moved the arm several times and lowered and raised the patient's head and head of bed.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET MAXIMAL
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5485064
• Report Number: 3006260740-2016-00083
• Device Sequence Number: 13693879
• Product Code: LJS
• UDI-Device Identifier: 00801741096303
• UDI-Public: (01)00801741096303(17)161128(10)REZF2307
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/12/2016

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: 11/28/2016
• Device Catalogue Number: CK000411
• Device Lot Number: REZF2307
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR