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

Catalog Number 305269

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/25/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 a consumer's wife injected him in his buttocks with a 25 g x 5/8 in.Bd integra 3 ml syringe with detachable needle.During the injection the needle broke off and remained in the injection site.The consumer went to an emergency department and received three x-rays.The x-rays confirmed that the needle remained in the consumer's buttocks but the er physician stated that removal would be too difficult and advised to leave it in place.

Manufacturer Narrative

Results: two open samples; one activated the other not, were returned for evaluation.A visual inspection of the activated sample showed that it appeared to be used as it contained a clear unknown medication.The spring from the activated sample had also been removed and returned with the sample.The needle hub was removed from the activated sample and the retracted needle was found inside the plunger rod.This likely was not the defective sample since the needle was contained inside the syringe.The un-activated syringe examined and no defects were noted.It was then activated and the needle retracted properly into the syringe.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 3084213.Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to confirm the customer¿s indicated failure mode.

• Brand Name: 25 G X 5/8 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: 5937617
• MDR Text Key: 54274497
• Report Number: 1213809-2016-00029
• 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: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 305269
• Device Lot Number: 3084213
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2013
• 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