MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE/NEEDLE

Catalog Number UNKNOWN

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Device expiration date: unknown.Device manufacture date: unknown.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 Description

It was reported that needle retraction failure occurred with a unspecified bd syringe/needle.The following information was provided by the initial reporter, ""(.) needle did not retract; that it was a spring loaded syringe and it did not retract, as it was supposed to.

Manufacturer Narrative

H.6.Investigation summary: a sample was not returned for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.H3 other text : see section h.10.

Event Description

It was reported that needle retraction failure occurred with a unspecified bd syringe/needle.The following information was provided by the initial reporter, ""(.) needle did not retract; that it was a spring loaded syringe and it did not retract, as it was supposed to.

• Brand Name: UNSPECIFIED BD SYRINGE/NEEDLE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8713396
• MDR Text Key: 149351037
• Report Number: 2243072-2019-01208
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other