MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 25 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE; SAFETY ENGINEERED SYRINGE AND NEEDLE

Catalog Number 305270

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/05/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.It is unknown if a sample will be returned for evaluation.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 partner injected her with a vitamin b12 injection in her deltoid muscle with a 25 g x 1 in.Bd integra 3 ml syringe with detachable needle.Upon completion of the injection, the needle may have broken off in the consumer's injection site.The consumer went to an emergency department where she received an x-ray.The x-ray did not visualize a broken needle.The consumer stated she can feel the needle inside her but there is no redness or swelling.No medications were prescribed and no further follow up was done.The er physician advised the consumer to keep an eye on the injection site and call him if there are any changes.The consumer also stated that there is a possibility the needle broke off or retracted and landed on the floor.

Manufacturer Narrative

Results: one open sample was returned for evaluation.A visual inspection revealed that the needle appeared as though it did not retract properly as the spring was coiled up within the syringe.Further inspection showed that the entire needle hub was present inside the syringe; it had retracted into the plunger rod and the needle hub and cannula assembly was fully intact.Since the needle assembly retracted into the plunger the spring should have also retracted into the plunger rod with the needle.A review of the device history record and quality notifications revealed no irregularities during the manufacture of the reported lot # 4202864.Conclusion: an absolute root cause for this incident in not able to be determined and bd was not able to confirm the customer¿s indicated failure mode and the evaluation of the returned sample showed that the full needle hub and cannula assembly had retracted into the plunger rod.

• Brand Name: 25 G X 1 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: 5879538
• MDR Text Key: 52228852
• Report Number: 1213809-2016-00025
• 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: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 305270
• Device Lot Number: 4202864
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2014
• 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