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

Catalog Number 305272

Device Problems Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problems Undesired Nerve Stimulation (1980); Device Embedded In Tissue or Plaque (3165)

Event Date 08/22/2016

Event Type  Injury  

Manufacturer Narrative

A sample is not available for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6021826.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.

Event Description

It was reported that a consumer's wife injected him in the buttocks with testosterone with a 22 g x 1 1/2 in.Bd integra 3 ml syringe with detachable needle and during the injection the needle broke off in the consumer's injection site.The consumer went to an emergency department where he received an x-ray that confirmed the needle was in his skin.He then had surgery to remove the broken needle but the surgery was unsuccessful and the needle was not removed.The initial reporter indicated that the needle has traveled further into the consumer's skin and is causing nerve issues.The consumer may have a more extensive surgery and is planning to see a doctor again.No additional information regarding further treatment, medical, and/or surgical interventions was provided.

• Brand Name: 22 G X 1 1/2 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: SAFETY ENGINEERED 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: 5934686
• MDR Text Key: 54144709
• Report Number: 1213809-2016-00028
• 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: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 305272
• Device Lot Number: 6021826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• 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): Required Intervention