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

Catalog Number	305283
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
The following information has been corrected: h.6 imdrf annex a code(s): a0510 -retraction problem, a0504 -leak/splash.
Event or Problem 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
• Common Device Name: 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
• Report Number: 1213809-2022-00348
• Device Sequence Number: 1348375
• Product Code: MEG
• UDI-Device Identifier: 00382903052837
• UDI-Public: 00382903052837
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 07/06/2022; 08/03/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 08/03/2022; 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown