MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 25 G X 5/8 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE; SYRINGE AND NEEDLE

Catalog Number 305269

Device Problem Break (1069)

Patient Problem Discomfort (2330)

Event Date 12/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device manufacture date: 01/16/2015 to 01/22/2015.Device evaluation: result - a sample has not been received for evaluation.A review of the device history record was performed for the reported lot 5015963.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.This lot was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Conclusion - without a sample, an absolute root cause for this incident cannot be determined.If a sample is returned, an investigation will be performed and a supplemental report will be submitted.

Event Description

It was reported that the patient injects testosterone into his thigh using the suspect device.During injection, the patient heard a click sound and the needle broke off in his thigh.He felt uncomfortable but in no pain.The customer went to the ed and had an x-ray but no needle was detected.Per report, the doctor states he could see a "path" where the needle would have gone but could not see the needle.The doctor told the patient that the needle was in fatty tissue and would work its way out.No additional medical interventions were provided at this time but the patient was to follow up with his doctor in 2 weeks for any signs or symptoms of infection.

• Brand Name: 25 G X 5/8 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: 6261726
• MDR Text Key: 65203586
• Report Number: 1213809-2017-00002
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 305269
• Device Lot Number: 5015963
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2016
• 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