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

Catalog Number	381034
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the representative samples and photograph submitted for evaluation.Bd received 39 sealed 20ga x 1.16in.Insyte autoguard units from lot number: 3167252.Additionally, one photo was provided.A blood escape time test was performed on all 39 units.17 units displayed liquid leaking through the actuator and out of the adapter.All 17 failed units were microscopically analyzed.No damage was observed, actuator was present, actuator did not appear to be sticking through the septum, and the septum did not appear to be damaged.The actuator also did not appear to be damaged.Your reported issue was confirmed.As the units tested did not display any damage to the septum or actuator, a root cause of why the leak occurred is undetermined.The samples may have also been exposed to high temperatures during shipping or storage which may affect the aging of the septum and possibly cause it to be more susceptible to leaking.Since no damage to the septum or the actuator was discovered, and the units were packaged more than a year ago and shipped to a far location, this root cause is possible.A device history record review showed no non-conformance's associated with this issue during the production of this batch.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(6).H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd insyte autog bc blood leaked beyond the blood control.The following information was provided by the initial reporter: the customer complained that the blood control valve do not function properly.

• Brand Name: BD INSYTE AUTOG 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: 19549618
• Report Number: 1710034-2024-00610
• Device Sequence Number: 6711430
• Product Code: FOZ
• UDI-Device Identifier: 00382903810345
• UDI-Public: (01)00382903810345
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 381034
• Device Lot Number: 3167252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown