MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 1ML BD¿ TUBERCULIN SYRINGE, 27GX1/2" BD PRECISIONGLIDE¿ DETACHABLE NEEDLE

Catalog Number 309623

Device Problem Difficult to Remove (1528)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation: a sample is available for evaluation but has not been received.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that the needle cap of the suspect device is difficult to remove.This has resulted in approximately 10-15 pre use needle stick injuries to the doctor.No medical interventions were performed.

Manufacturer Narrative

Results: eight unused and sealed samples were returned for evaluation.A visual inspection revealed no extra adhesive was found on or around the shields.The syringes were tested for shield removal force and the results were within specifications.Two of the samples were above the average removal force but still within specifications.Specifications for shield removal force is from greater than or equal to.5 lbs to less than or equal to 5.5 lbs.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6241524.Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: 1ML BD¿ TUBERCULIN SYRINGE, 27GX1/2" BD PRECISIONGLIDE¿ DETACHABLE NEEDLE
• Type of Device: TUBERCULIN SYRINGE
• 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: 6418798
• MDR Text Key: 70627934
• Report Number: 1213809-2017-00014
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110771
• 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,Followup
• Report Date: 04/18/2017

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: Physician
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 309623
• Device Lot Number: 6241524
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2016
• 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