MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 25 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE; SYRINGE AND NEEDLE

Catalog Number 305270

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 10/21/2015

Event Type  Injury  

Manufacturer Narrative

This event occurred at the end of (b)(6).As the exact date of the event is unknown, the date received by the manufacturer is used.A sample is available for evaluation but has not been received.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that the patient had the needle from a bd integra 3 ml syringe break off in her left arm.The patient went to the emergency department and the needle was successfully removed.The patient notes also having imaging studies done related to the needle break off but is unclear as to the dates or specific tests performed.

Manufacturer Narrative

Result - a sample was not returned for evaluation.A review of the device history record cannot be completed as the lot number was not provided for this incident.Conclusion - a potential root cause for this incident is reuse.Without a sample, an absolute root cause for this incident cannot be determined.A sample was not returned for evaluation.

• Brand Name: 25 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: 5217871
• MDR Text Key: 30998874
• Report Number: 1213809-2015-00012
• Device Sequence Number: 1
• Product Code: MEG
• 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: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 305270
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2015
• Initial Date FDA Received: 11/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention