MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 4F FULL TRAY (; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	9174108
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/14/2016
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 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 a detached dilator handle was confirmed and the cause was determined to be manufacturing related.The product returned for evaluation was a 4.5fr vessel dilator.The hdpe dilator tubing had separated from the white locking handle.Blood and usage residue could be seen within the dilator.A visual review of the dilator tubing showed that the tubing anchors were present near the proximal end of the tubing.The outside diameter of the tubing was measured to be within specification.Microscopic examination of the white locking handle revealed voids in the inner canal surface which makes the connection with the hdpe dilator tubing.The voids were on opposing sides of the canal.A similar review on a non-complainant samples showed that these voids did not exist.The observed voids on the inner locking handle canal would have prevented proper securement of the dilator tubing to the handle.The sample was forwarded to the manufacturing facility for further review.A lot history review (lhr) of rezl2159 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On (b)(6) 2016-per sales representative, user facility reported that the tip of the dilator broke off during insertion.No patient harm reported.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 4F FULL TRAY (
• 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: 5638179
• Report Number: 3006260740-2016-00214
• Device Sequence Number: 564189
• Product Code: LJS
• UDI-Device Identifier: 00801741035548
• UDI-Public: (01)00801741035548(17)170628(10)REZL2159
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/14/2016

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: 06/28/2017
• Device Catalogue Number: 9174108
• Device Lot Number: REZL2159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2016
• Initial Report FDA Received Date: 05/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1