MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW; 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	08/19/2019
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that the syringe integra 3ml w/ndl 21x1-1/2 rb tw has been found experiencing needle retraction failure during use.The following has been provided by the initial reporter: faulty retractable needle ¿ only released 200 mg of medication instead of 300 mg it should have.Retractable needle did not retract leaving medication in the syringe.
Event or Problem Description
It has been reported that the syringe integra 3ml w/ndl 21x1-1/2 rb tw has been found experiencing needle retraction failure during use.The following has been provided by the initial reporter: 1) faulty retractable needle, only released 200 mg of medication instead of 300 mg it should have 2) retractable needle did not retract leaving medication in the syringe.
Additional Manufacturer Narrative
H.6.Investigation summary: one sealed biohazard bag containing a used integra syringe was received.The sample was visually evaluated.The syringe was observed to have medication in its fluid path.The plunger rod¿s thumb rest was near the barrel shroud, and the stopper was observed to be at 0.2 ml marking with approximately 0.1ml of medication remaining.The cutter was exposed through the stopper and confirmed to have cut a hole through the needle hub.The needle hub was carefully unscrewed, and the needle was confirmed to have been retracted into the syringe.The medication was observed to be quite viscous.Based on the sample evaluation, no defects were observed with the returned device.It is possible the needle retraction mechanism was activated prematurely if too much pressure was applied during use near the end of administration of medication.Combined with the viscous nature of the medication, this could trigger the retraction activation.Unused samples would be required for testing to further investigate whether there are any manufacturing defects present with the retraction mechanism.No manufacturing defects were confirmed in the sample 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 section h.10.

• Brand Name: SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 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: 8972082
• Report Number: 1213809-2019-00904
• Device Sequence Number: 3079747
• 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): 10/21/2019

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: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 305274
• Device Lot Number: 7177705
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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