MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD INTEGRA¿ SYRINGE, RETRACTING NEEDLE; SYRINGE AND NEEDLE

Catalog Number	305311
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during client injection, the vaccine leaked out between the syringe and the needle of the bd integra¿ syringe, retracting needle.The client needed to be injected an extra time.Found during use.No report of serious injury or medical intervention noted.
Additional Manufacturer Narrative
Investigation summary: no sample was available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause or identify any corrective actions needed.A review of the device history record revealed zero defects noted during this production run.Investigation conclusion: no sample was available.Root cause could not be determined.
Event or Problem Description
It was reported that during client injection, the vaccine leaked out between the syringe and the needle of the bd integra¿ syringe, retracting needle.The client needed to be injected an extra time.Found during use.No report of serious injury or medical intervention noted.

• Brand Name: BD INTEGRA¿ SYRINGE, RETRACTING NEEDLE
• Common Device Name: SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7494154
• Report Number: 1911916-2018-00192
• Device Sequence Number: 16573241
• Product Code: MEG
• UDI-Device Identifier: 00382903053117
• UDI-Public: 00382903053117
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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: 10/31/2020
• Device Catalogue Number: 305311
• Device Lot Number: 5287717
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 07/30/2018
• 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