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	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Initial reporter phone# (b)(6).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 premature retraction occurred during use with a bd integra¿ 3 ml syringe with detachable needle.The following information was provided by the initial reporter, "faulty retractable needle ¿ when administering depot needle started to retract making administration impossible.Drug evident on skin and syringe not secure and as removed it continued to retract.(no drug administered to client from this needle.) therefore another needle used and administered in a different site.(no issue with the second needle.)".
Additional Manufacturer Narrative
H.6.Investigation summary: a single used integra syringe was received inside an opened package from batch #6320737 (p/n305274), all in a biohazard bag.The sample was visually evaluated.The syringe had medication residue inside and outside the fluid path, including on the barrel surface.The stopper was at the bottom out position at the zero line, while the plunger¿s thumb rest was below the barrel shroud.The needle was capped and the cannula was confirmed to have been retracted.Based on the sample evaluation, no defect was observed with the product.It is unknown whether the retraction occurred slightly before the stopper was bottomed out.However, it is possible if the medication was viscous and enough force was applied to the plunger it could trigger the retraction mechanism prior to the bottom out position.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 premature retraction occurred during use with a bd integra¿ 3 ml syringe with detachable needle.The following information was provided by the initial reporter, "faulty retractable needle ¿ when administering depot needle started to retract making administration impossible.Drug evident on skin and syringe not secure and as removed it continued to retract.(no drug administered to client from this needle.) therefore another needle used and administered in a different site.(no issue with the second needle.)".

• 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: 9180584
• Report Number: 1213809-2019-01030
• Device Sequence Number: 2649015
• 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): 01/13/2020

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 Catalogue Number: 305274
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 01/13/2020
• 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