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

Catalog Number	305274
Medical Device Problem Codes	Leak/Splash (1354); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd intregra¿ syringe with detachable needle would not retract when administering the depot injection.Additionally, it was reported that the plunger was "stiff" halfway through the administration before "shooting off" the depot injection "very fast", causing spillage.The following information was provided by the initial reporter: the needle does not retract when staff is administering depot injection.On some occasions staff has noted that the syringe is very stiff halfway, administration of depot injection then shoots off the depot injection very fast causing spillage.We had a near-miss in the clinic where the staff was reported to have almost been cut/injured as the needle/syringe jammed when they were administering depot injection.".
Event or Problem Description
It was reported that the bd intregra¿ syringe with detachable needle would not retract when administering the depot injection.Additionally, it was reported that the plunger was "stiff" halfway through the administration before "shooting off" the depot injection "very fast", causing spillage.The following information was provided by the initial reporter: " the needle does not retract when staff is administering depot injection.On some occasions staff has noted that the syringe is very stiff halfway, administration of depot injection then shoots off the depot injection very fast causing spillage.We had a near-miss in the clinic where the staff was reported to have almost been cut/injured as the needle/syringe jammed when they were administering depot injection.".
Additional Manufacturer Narrative
H.6.Investigation summary: five 3ml integra syringes with needles attached in fully sealed blister packs from batch 8317519 (p/n 305274) were received and evaluated.No visual defect were observed.All five syringes were removed from the packages.The plunger rods were depressed, and the retraction mechanism activated as expected.The reported defect was not identified in the samples received.Furthermore, 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.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.H3 other text : see section h.10.

• Brand Name: BD INTREGRA SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9728165
• Report Number: 1213809-2020-00117
• Device Sequence Number: 741248
• Product Code: MEG
• UDI-Device Identifier: 00382903052745
• UDI-Public: 00382903052745
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (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): 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 305274
• Device Lot Number: 8317519
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other