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

Catalog Number	382634
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Address information was not provided, therefore, xx was used as a place holder.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that an unspecified amount of bd insyte autoguard bcs encountered resistance while retracting the needle.The following information was provided by the initial reporter: end user is having resistance when pulling back the needle which is causing blood to leak out the back end and looks like the valve is being broken to remove the needle.Additional information received 03/08/2024: date of events unknown no sample available did the event directly, or indirectly involve a patient or user? yes several occurrences.
Additional Manufacturer Narrative
Additional information: additional event details from customer added to b5.Investigation results: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.The dhr for lot 3342665 has been reviewed.Subassembly lot 3342665 material 7000bcw34 was built on afa line 9 from 10dec023 through 14dec2023.Final lot was packaged on pkg line 10 from 17dec2023 through 18dec2023 for a total quantity of (b)(4).No related quality issues or process deviations were found.This complaint type will continue to be trended within the post market surveillance process and any determined escalation will be managed there.
Event or Problem Description
Additional information: no problems with the needle retraction spring.Once the colored part is off the hub, the needle comes in contact with colored hub creating resistance when threading.There has been no visible damage seen.Blood exposures to any surfaces have not been reported, other than the bed, floor and patient.No reports of serious injuries or harm.No medical or surgical interventions were needed for any events.Reported from multiple rns, many different patients, and lot numbers were not noted.It seems it is mainly the non-blood control needles.The main problem seen is resistance when threading due to needle touching the plastic colored part of the cannula once it is unseated.

• Brand Name: BD INSYTE AUTOGUARD BC
• 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: 18934829
• Report Number: 1710034-2024-00200
• Device Sequence Number: 7043123
• Product Code: FOZ
• UDI-Device Identifier: 00382903826346
• UDI-Public: (01)00382903826346
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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: Other
• Device Catalogue Number: 382634
• Device Lot Number: 3342665
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown