MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER, 5 F DL, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	CK000688
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2018
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, frequency 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 frayed wire was confirmed, and the cause appeared to be use related.One 3cg stylet was returned for investigation.The power picc was not returned for investigation.The stylet had been retracted through the septum on the t-lock extension set and the section of core wire proximal to the extension set was coiled.The white insulated wire was not bundled in its packaged state.The twist clip was still attached to the white insulated wire.Two tears were observed in the white insulated wire and approximately 8mm of the underlying wire were exposed in each location.A microscopic examination revealed that the tears in the insulation were rough and granular.Impressions were observed in the white insulation.This type of damage can occur if the bundled wire is forcibly straightened with the twist clip still attached.Due to the condition of the sample, it appeared that the damage occurred during use.A lot history review (lhr) of recn2901 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported that the 3cg wire was noted to be frayed in two places during placement of the device.It was stated that there was no patient harm.

• Brand Name: POWERPICC SOLO CATHETER, 5 F DL, 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7539196
• Report Number: 3006260740-2018-01062
• Device Sequence Number: 204624
• Product Code: LJS
• UDI-Device Identifier: 00801741136542
• UDI-Public: (01)00801741136542
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

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 Catalogue Number: CK000688
• Device Lot Number: RECN2901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1