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

Catalog Number 305270

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)

Patient Problems Fluid Discharge (2686); Test Result (2695); Device Embedded In Tissue or Plaque (3165)

Event Date 09/10/2015

Event Type  Injury  

Manufacturer Narrative

A sample is available for investigation but has not been received.A supplemental will be submitted upon completion of the device evaluation.

Event Description

Per report, an integra syringe needle broke off during injection of testosterone into buttocks.The customer went to the ed and received an x-ray.The needle was not seen.Customer states he has liquid coming out of injection site and can feel a bump.Consumer went to the pharmacy and had the syringe inspected.It was determined that the needle was not inside the syringe.No additional information was provided by the customer.

Manufacturer Narrative

Result - a sample was not returned for evaluation.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 4024038.Conclusions - as there was no actual sample returned for evaluation, an absolute root cause for this incident cannot be determined.

Manufacturer Narrative

Device evaluation: one used, activated bd 3ml 25g integra retractable syringe (cat # 305270, lot # 4024038) was received out of an open blisterpack on 12/1/2015.Issue - needle break off in injection site.Result: the sample was broken down and revealed the 25g cannula having retracted and resting inside the barrel.Conclusion: this issue is not confirmed based off the sample investigation as the needle was found in the returned sample.Issue - leakage of medication at the injection site.Result: the returned sample was examined and no damage, cracks or deformity of the plunger, stopper, needle hub or syringe barrel was observed.On integra syringes, if the medication is too viscous, or if the needle gauge is too small, the administrator would experience counter pressure when trying to dispel medication.In some cases, the blade might protrude through the stopper ahead of time, for instance halfway through the administration, and the syringe may bottom out or jam with approximately 0.1 ml of the medication still within the barrel.The above scenario may cause this medication to leak out the barrel hub.Conclusion: this issue is not categorized as a device malfunction and cannot be confirmed based on sample investigation.Issue - bump on the injection site.Result: the needle was inspected under magnification for any issues with the needle tip that would cause a bump or swelling on the injection site.The tip was noted to be dull.It could not be established if this was since the needle had been used.There is no indication of any issue while injecting with reference to pain or difficult injection per the customer's complaint verbatim.The result of the device history review indicates that all visual inspections were performed as per requirement with no issues related to the defect described in this complaint observed during manufacturing process of batch 4024038.All visual inspections were also performed as per requirement with no issues observed during manufacturing process of the assembly batches used to produce the packaged batch 4024038.No visual fm could be seen on the needle that could have contributed to an allergic reaction.Conclusion: this issue is confirmed based on the dull needle point noted.

• Brand Name: 25 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: SYRINGE AND NEEDLE, BD SAFETY-ENGINEERED DEVICE
• 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: 5123945
• MDR Text Key: 27433317
• Report Number: 1213809-2015-00008
• 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: Followup,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 305270
• Device Lot Number: 4024038
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2014
• 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