MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE AUTOG BC WING; PERIPHERAL IV CATHETERS

Catalog Number	382934
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd insyte ag bc global wing piv adapter- iv tubing disconnected.The following information was provided by the initial reporter, translated from french to english: kt iv (pink catheter without wings) fitted this lunchtime to a patient, catheter well fixed and passing well.This evening, the infusion tubing (perfuseur gravite 3voies r30cm deconnectable per3fl25bpaf - didactic) unscrewed from the catheter.Hydration passed by.It's not the first time this has happened and the risk of haemorrhage is +++.Several reports please give us your analysis of this fault and let us know if you have received any similar reports from other users.
Additional Manufacturer Narrative
Investigation results: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE AUTOG BC WING
• Common Device Name: PERIPHERAL IV CATHETERS
• 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 (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21505587
• Report Number: 2243072-2025-00183
• Device Sequence Number: 19933476
• Product Code: FOZ
• UDI-Device Identifier: 00382903829347
• UDI-Public: (01)00382903829347
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2025

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: 382934
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 04/14/2025
• 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