MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 21X1 RB TW; PISTON SYRINGE

Catalog Number	305273
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe integra 3ml w/ndl 21x1 rb tw needle retraction prematurely.This occurred on 2 occasions.The following information was provided by the initial reporter: needle retracted prematurely.Needle retracted spontaneously while administering medication meaning that not all of the medication could be administered.Has happened on several occasions over the last couple of weeks.
Additional Manufacturer Narrative
H.6.Investigation: one loose used integra syringe from unknown batch and five opened and resealed boxes containing sealed integra product were received.190 samples were from batch #8095530 (p/n 305273), 186 were from batch #9232754 (p/n 305272), 21 were from batch #9046809 (p/n 305271).The samples were visually evaluated.No visible defects were observed in the sealed packaged product.The used sample was observed to have its cutter activated with the stopper located at 0.2ml mark.The cannula was observed to have been retracted and the plunger rod thumb rest was above the barrel shroud.The fluid path contained unidentified liquid.The observations were consistent with premature retraction activation.All of the unused sealed packaged product was tested for retraction activation forces per procedure.Only one syringe from batch #9232754 (305272) was found to be outside specification for plunger rod collapse force.The value was slightly above the upper limit of specification, which would make it slightly more difficult to activate the retraction mechanism.All other samples from the three batches and products were found to be within product specification.Even though the condition of premature retraction was observed in the one used sample, this condition was not confirmed in the representative samples received.Based on the test data of the unused 397 samples the cutting force was in the middle to high end of the product specification.It is unlikely that the observed condition in the used sample was a result of the manufacturing process.It is possible that the premature retraction in the used sample was related to the medication viscosity and speed of administration.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported that syringe integra 3ml w/ndl 21x1 rb tw needle retraction prematurely.This occurred on 2 occasions.The following information was provided by the initial reporter: needle retracted prematurely.Needle retracted spontaneously while administering medication meaning that not all of the medication could be administered.Has happened on several occasions over the last couple of weeks.

• Brand Name: SYRINGE INTEGRA 3ML W/NDL 21X1 RB TW
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11468241
• Report Number: 1213809-2021-00124
• Device Sequence Number: 3791555
• Product Code: MEG
• UDI-Device Identifier: 00382903052738
• UDI-Public: 00382903052738
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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 Expiration Date: 03/31/2023
• Device Catalogue Number: 305273
• Device Lot Number: 8095530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1