MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS PICC 4F SINGLE-LUMEN PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
During insertion of perq basic kit in patients the catheter along with stylet bend inside the vein and unable to do the procedure.It was stated this occurred with four devices.This report addresses the second device.
Additional Manufacturer Narrative
The information provided by bd 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 bd.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 bend in the catheter was confirmed, and the cause appeared to be associated with use of the device.One 4 fr s/l per-q-cath picc was returned for investigation.The catheter was received with the stylet in the lumen.The stylet had been retracted through the catheter.The distal tip of the stylet coincided with the 49cm depth mark.The catheter length had not been modified and extended to the 65cm depth mark.It is unknown if an attempt was made to insert the catheter with the stylet retracted in the lumen.The stylet was bent just proximal to the septum on the t-lock extension set.Another bend in the stylet caused a bend in the catheter near the 12cm depth mark.A functional test revealed no leaks in the catheter.The stylet was within specification.It was reported that the catheter and stylet bent during insertion.Due to the condition of the catheter, it appears that the damage occurred during use and could be associated with the insertion technique, insertion angle, or patient position.
Event or Problem Description
During insertion of perq basic kit in patients the catheter along with stylet bend inside the vein and unable to do the procedure.It was stated this occurred with four devices.This report addresses the second device.

• Brand Name: PER-Q-CATH PLUS PICC 4F SINGLE-LUMEN PICC
• 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: 8034642
• Report Number: 3006260740-2018-03119
• Device Sequence Number: 19207261
• Product Code: LJS
• UDI-Device Identifier: 00801741074875
• UDI-Public: (01)00801741074875
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 4134105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1