MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Catalog Number	305274
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: 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 needle did not retract with a bd integra¿ 3 ml syringe with detachable needle.The following information was provided by the initial reporter: (4 of 4).Impossible to push the plunger to the full length of the barrel, the seal stopped, leaving 0.2mls of the solution in the barrel, and the needle did not retract.
Additional Manufacturer Narrative
H.6.Investigation: six 3ml integra syringes with needles in fully sealed blister packs confirmed to be from batch #7177705 (b)(4) were received and evaluated.All the syringes were received with the stopper in the 0.2ml position.One syringe was removed from the package and disassembled.It was observed there was a small hub deformation but would not affect the retraction mechanism.Five syringes visually inspected though the package with no observable defects.The six samples were tested for retraction activation force.All samples were acceptable per product specification and the plunger rods were bottomed out.Although no defect was observed, the premature retraction described may be due to the density of the medication used and how the medication was being administered at the time.Root cause not defined since defects were not confirmed in the samples received.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.H3 other text : see h.10.
Event or Problem Description
It was reported that the needle did not retract with a bd integra¿ 3 ml syringe with detachable needle.The following information was provided by the initial reporter: (4 of 4) impossible to push the plunger to the full length of the barrel, the seal stopped, leaving 0.2mls of the solution in the barrel, and the needle did not retract.

• Brand Name: BD INTEGRA 3 ML 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: 8654325
• Report Number: 1213809-2019-00573
• Device Sequence Number: 11281592
• Product Code: MEG
• UDI-Device Identifier: 30382903052746
• UDI-Public: 30382903052746
• 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): 07/12/2019

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: 06/30/2022
• Device Catalogue Number: 305274
• Device Lot Number: 7177705
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 07/12/2019
• 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