MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PPICC 5F DL RN; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Knotted (1340)

Patient Problem No Information (3190)

Event Type  malfunction  

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of 17hb5026 showed no other similar product complaint(s) from this lot number.

Event Description

The facility reported to the sales rep that the picc became knotted during placement.The picc was removed.

Manufacturer Narrative

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 knot in the picc was confirmed, and it appeared that the picc was damaged during use.One 30.9cm segment of 5fr d/l powerpicc tubing was returned for investigation.Blood residue was observed within the lumen.The catheter was received with an overhand knot in the tubing.The knot was located between the 42 and 43 cm depth marks and was positioned 5.1cm from the distal tip of the catheter.The knot had been tightened.It was reported that the picc became knotted during placement.The catheter may have inadvertently looped around and through itself within the vessel.No portion of the stylet was contained with the knot.Due to the condition of the returned sample, it was determined that the damage occurred during use.A lot history review (lhr) of 17hb5026 showed no other similar product complaint(s) from this lot number.

Event Description

The facility reported to the sales rep that the picc became knotted during placement.The picc was removed.

• Brand Name: DOT PPICC 5F DL RN
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7231354
• MDR Text Key: 98860200
• Report Number: 3006260740-2018-00067
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741141584
• UDI-Public: (01)00801741141584
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CK000754
• Device Lot Number: 17HB5026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1