MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 23 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE; SYRINGE AND NEEDLE

Catalog Number 305271

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

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 the needle did not retract on a 23 g x 1 in.Bd integra¿ 3 ml syringe with detachable needle after use.No injury or medical intervention.

Manufacturer Narrative

Results: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for safety failure with the incident lot was not observed.A review of the device history record revealed no irregularities during the manufacture of the reported lot number.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: 23 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7001230
• MDR Text Key: 92074014
• Report Number: 1213809-2017-00233
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903052715
• UDI-Public: 30382903052715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 305271
• Device Lot Number: 4024044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other