MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD 50 ML LUER LOCK SYRINGE

Catalog Number 300865

Device Problems Excess Flow or Over-Infusion (1311); Material Deformation (2976)

Patient Problem Overdose (1988)

Event Date 11/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The medical device expiration date is unknown as the lot number is unknown.(b)(6) device manufacture date is unknown as the lot number is unknown.Device evaluation: result - one used sample of a 50 ml ll syringe without the blister was received connected to a tube.On visual inspection of the sample, it can be observed that the thread of the tip is damaged and there is leakage between the tube way and the syringe thread connected.The syringe was decontaminated and observed at 10x.Damage from overscrewing can be confirmed.Tip verification was performed on the returned sample and found within specification.Thread verification was performed and found within specification.Thread of the tube way was verified with male gauge pass/no pass.The syringe was filled with water and connected to the tube way.Leakage was observed when discharged.Therefore, it was determined that damage to the thread caused the leakage.A review of the device history record cannot be completed as the lot number was not provided for this incident.During the manufacturing process, final products are sampled and subjected to visual inspections according to procedure.Conclusion - based off the returned sample, the damage to the thread can be contributed to overscrewing the device.See manufacturer narrative.

Event Description

It was reported that the syringe tip of the suspect device was deformed and norepinephrine leaked between the syringe and the tube.The nurse attempted to seal it by screwing it on harder but was unsuccessful.The patient received an extra infusion of blood and saline.First, 600 ml of saline was given followed by two infusions of 200 ml albumin.The patient then received a blood transfusion as "the patient was in need of blood anyway" but did receive one extra infusion as a result of this incident.

• Brand Name: BD 50 ML LUER LOCK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6190076
• MDR Text Key: 62858149
• Report Number: 3003152976-2016-00014
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 300865
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/20/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention