MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA SYRINGE; SAFETY SYRINGE W/ NEEDLE

Catalog Number 305283

Device Problems Crack (1135); Leak/Splash (1354); Retraction Problem (1536)

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

Event Date 05/24/2022

Event Type  malfunction  

Event Description

It was reported that the bd integra syringe experienced device damage while still considered operable, and leakage.The following information was provided by the initial reporter: upon minimal pressing of the pestle, the syringe broke and the medication flowed out at the top and bottom.Subsequently, the system was also defective.- what medication/fluid was used: temesta 4mg - did a serious injury occur? no - did any medical action have to take place as a result of this incident?: no.

Manufacturer Narrative

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 bd integra syringe experienced device damage while still considered operable, and leakage.The following information was provided by the initial reporter: upon minimal pressing of the pestle, the syringe broke and the medication flowed out at the top and bottom.Subsequently, the system was also defective.- what medication/fluid was used: temesta 4mg, - did a serious injury occur? no, - did any medical action have to take place as a result of this incident?: no.

Manufacturer Narrative

H.6 imdrf annex a code(s): a0510 -retraction problem, a0504 -leak/splash.H.6 investigation summary: one loose sample of a 3ml integra syringe (p/n 305283) was received.A visual evaluation performed, no barrel cracked or damaged observed, however; the cutter had cut thru the stopper causing the fluid to leak out of the stopper, but the needle was still inside the needle hub as it had not been activated.The condition observed is non-conforming per product specification.Potential root cause for the premature retraction and needle retraction failure defects are associated with the assembly process.The batch number is unknown, therefore defective rate cannot be identified and corrective actions are not necessary.The batch number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Potential root cause for the premature retraction and retraction failure defects are associated with the assembly process.

Manufacturer Narrative

The following information has been corrected: h.6 imdrf annex a code(s): a0510 -retraction problem, a0504 -leak/splash.

Event Description

It was reported that the bd integra syringe experienced device damage while still considered operable, and leakage.The following information was provided by the initial reporter: upon minimal pressing of the pestle, the syringe broke and the medication flowed out at the top and bottom.Subsequently, the system was also defective.- what medication/fluid was used: temesta 4mg, - did a serious injury occur? no, - did any medical action have to take place as a result of this incident?: no.

• Brand Name: BD INTEGRA SYRINGE
• Type of Device: SAFETY SYRINGE W/ NEEDLE
• 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: 14756783
• MDR Text Key: 296796583
• Report Number: 1213809-2022-00348
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 00382903052837
• UDI-Public: 00382903052837
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305283
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2022
• 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