MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE

Model Number 309628

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/07/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the needle pulled out of the bd syringe luer-lok¿ tip hub and remained in the patient after medication administration.The following information was provided by the initial reporter: the needle came away from the syringe and remained in the patient after medication was administered.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 19-apr-2022.H.6.Investigation: one sample and one photo was provided to our quality team for investigation.The syringe evaluated and no defects with the syringe could be confirmed.Since no samples displaying the reported condition were received for syringe, a potential root cause could not be defined and corrective actions are not necessary.A device history record review was completed for provided lot number 1312509.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

Event Description

It was reported that the needle pulled out of the bd syringe luer-lok¿ tip hub and remained in the patient after medication administration.The following information was provided by the initial reporter: the needle came away from the syringe and remained in the patient after medication was administered.

• Brand Name: BD SYRINGE LUER-LOK¿ TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13876456
• MDR Text Key: 287791902
• Report Number: 1213809-2022-00155
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

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
• Device Operator: Health Professional
• Device Model Number: 309628
• Device Catalogue Number: 309628
• Device Lot Number: 1312509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1