MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 F SL POWERPICC SOLO 3CG MB; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	CK000408
Health Effect - Clinical Code	No Information (3190)
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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of knotted catheter is confirmed, but cause is unknown.Possible causes include insertion technique.One photograph was returned and visually examined.The photograph shows one powerpicc catheter.The catheter displays red residue, indicating use, and appears to be knotted near the visible end.It is possible that the catheter inadvertently folded over itself and was twisted into a knot within the vein.A lot history review (lhr) of reaq0768 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
(b)(6) 2016- per sales representative, facility reported that the picc was placed with slight resistance then threaded easily; sherlock and ekg technology verified placement but then catheter would not flush and there was no blood return.It was stated that in an attempt to pull the picc out it became stuck.The physician was notified and a 5 fr dilator was placed over the picc and then the dilator was removed.It was stated that the picc was pulled and it came out intact with a small knot at the end.A pressure dressing was applied.

• Brand Name: 4 F SL POWERPICC SOLO 3CG MB
• 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: 6115181
• Report Number: 3006260740-2016-00613
• Device Sequence Number: 13591134
• Product Code: LJS
• UDI-Device Identifier: 00801741096273
• UDI-Public: (01)00801741096273(17)170828(10)REAQ0768
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2016

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: 08/28/2017
• Device Catalogue Number: CK000408
• Device Lot Number: REAQ0768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2016
• Initial Report FDA Received Date: 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1