MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Model Number 305271

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the stopper separated from the plunger while using the bd integra¿ syringe with detachable needle.The following information was provided by the initial reporter: the plunger rod separated from the rubber stopper.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 03-may-2022.H6: investigation summary: one loose 3ml integra syringe (p/n 305271) was received.The sample was visually evaluated.The syringe was observed to have its cutter activated through the stopper with the needle not retracted.This would indicate a premature collapse of the plunger rod.The stopper did not appear to be insecure or separated from the plunger.Additionally, the plunger head was observed and no molding defects that could have contributed to stopper separation were present.The premature collapse condition indicated by the sample was non-conforming per product specification.Potential root cause for the premature collapse defect is associated with the assembly process.The batch number is unknown, therefore defective rate cannot be identified and corrective actions are not necessary.

Event Description

It was reported that the stopper separated from the plunger while using the bd integra¿ syringe with detachable needle.The following information was provided by the initial reporter: the plunger rod separated from the rubber stopper.

• Brand Name: BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE
• 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: 14187708
• MDR Text Key: 290055676
• Report Number: 1213809-2022-00230
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: 30382903052715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 305271
• Device Catalogue Number: 305271
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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