MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD WINGED; PERIPHERAL IV CATHETERS

Catalog Number	381534
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autoguard winged has a damaged tip.The following information was provided by the initial reporter: catheter looks frayed towards the tip of the catheter.
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.An additional lot number sample was provided in this complaint for material number 381534, lot # 3228133, mfg: 2023-08-21, exp: 2026-07-31.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: BD INSYTE AUTOGUARD WINGED
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18591249
• Report Number: 1710034-2024-00041
• Device Sequence Number: 8124966
• 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
• Report Date (Section B): 01/26/2024

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 381534
• Device Lot Number: 3269681
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown