MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS UNSPECIFIED BD INTEGRA¿ RETRACTING SAFETY SYRINGE; SAFETY ENGINEERED SYRINGE AND NEEDLE

Catalog Number UNKNOWN

Device Problem Difficult to Insert (1316)

Patient Problem Chemical Exposure (2570)

Event Date 01/24/2017

Event Type  malfunction  

Manufacturer Narrative

Of note, this complaint was initially evaluated as a non-reportable incident on 1/27/2017.At that time, there was no indication that the device used was a safety engineered device.On 3/13/2017, the customer returned a sample of a safety engineered device.Therefore, this complaint was re-evaluated for mdr reportability and was determined to be mdr reportable for a safety mechanism failure during use.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.Udi #: unknown.

Event Description

It was reported that a consumer used an unspecified bd integra¿ retracting safety syringe to injecting testosterone into his buttock.The consumer stated that the needle would not penetrate his skin and retracted into the syringe and medicine ran down his leg.There was no report of injury or medical intervention.

Manufacturer Narrative

Results: one used sample without catalog or lot numbers was returned for evaluation.A visual inspection revealed the needle hub was not attached to the syringe and the retracted needle was inside the plunger rod chamber.A review of the device history record could not be performed as a lot number was not provided for this incident.Conclusion: although the needle was confirmed to be inside the syringe plunger rod chamber, an absolute root cause for the premature safety activation cannot be determined.Our quality engineer notes that it is possible the needle retracted prematurely because testosterone was injected.Testosterone is a viscous medication and for viscous medications it is recommended to use a 21 or 22 gauge needle since the larger gauge size would improve flow of the medication.

• Brand Name: UNSPECIFIED BD INTEGRA¿ RETRACTING SAFETY SYRINGE
• 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: 6474074
• MDR Text Key: 72276788
• Report Number: 1213809-2017-00024
• 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: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other