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	09/02/2019
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.Retractable needle did not retract leaving medication in the syringe.Since this incident we have had another similar case involving a different batch and a different nurse.
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.2)retractable needle did not retract leaving medication in the syringe.Since this incident we have had another similar case involving a different batch and a different nurse.
Additional Manufacturer Narrative
Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review could not be performed as lot number was unknown.

• 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: 9082941
• Report Number: 1213809-2019-00941
• Device Sequence Number: 11416982
• 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): 10/02/2019

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 09/02/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/02/2019
• 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