MAUDE Adverse Event Report: BECTON DICKINSON INSYTE AUTOGUARD WINGED PNK 20GA X 1.16I; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	381534
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Materials#: 381534, batch#: unknown.It was reported by the customer that catheter looks frayed towards the tip of the catheter.Verbatim: catheter looks frayed towards the tip of the catheter.
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if a device evaluation and/or device history review is completed.Patient problem code: f27 ¿ no patient involvement.Device problem code: a0202 - defective component.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Investigation findings: our quality engineer inspected the photographs and samples submitted for evaluation.Bd received three photographs which display similarities to the unit with an unknown lot number.In addition, three samples were received.The units received from lot numbers 3228133 and 3269681 were found to have a small flash located on the tip of the catheter which was graded unacceptable.Your reported issue was confirmed and determined to be manufacturing related.During manufacturing, the flash may form and flow lines may get distorted due to lube temperatures being too low during tipping or if there is insufficient lube due to die /coil misalignment.The third unit displayed a long strip flash of catheter material on the side of the catheter which was also found unacceptable.During manufacturing, this may be caused by die build up or hard water on the surface of the tubing guides.A device history record review showed no non-conformances associated with this issue during the production of these batches.The appropriate personnel have been notified and complaints received for this device and reported condition will continue to be tracked and trended.

• Brand Name: INSYTE AUTOGUARD WINGED PNK 20GA X 1.16I
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18284311
• Report Number: 1710034-2023-01411
• Device Sequence Number: 17689601
• Product Code: FOZ
• UDI-Device Identifier: 00382903815340
• UDI-Public: (01)00382903815340
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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: 381534
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown