MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 22 G X 1 1/2 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE; SYRINGE AND NEEDLE

Catalog Number 305272

Device Problems Detachment Of Device Component (1104); Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)

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

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

Results: it is unknown if a sample will be returned for evaluation.A review of the device history record could not be performed as a lot number for this incident was not provided.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.It is unknown if a sample is available for evaluation.

Event Description

It was reported that a consumer used a 22 g x 1 1/2 in.Bd integra 3 ml syringe with detachable needle to give himself an injection and the needle broke off in his stomach.The consumer went to a hospital and received an x-ray.The x-ray did not visualize the needle and the consumer was told that there was no needle within his injection site.

• Brand Name: 22 G X 1 1/2 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: 5533691
• MDR Text Key: 41417249
• Report Number: 1213809-2016-00015
• 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
• Report Date: 03/29/2016

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: 305272
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2016
• Initial Date FDA Received: 03/29/2016
• 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