MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 1 ML BD¿ TB SYRINGE WITH 27G X 1/2IN. BD PRECISIONGLIDE¿ DETACHABLE NEEDLE; TUBERCULIN SYRINGE

Catalog Number 309623

Device Problem Difficult to Remove (1528)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

Results: 14 sealed samples were returned for evaluation.The samples were tested for shield removal force.The maximum shield removal force specification is 5.5 lbs.Of the 14 samples, one failed with a shield removal force of 5.94 lbs.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6241524.Conclusion: although the customer's indicated failure mode was confirmed, an absolute root cause for this incident cannot be determined.Our quality engineer states the sample size received from customer (14 pieces) does not represent the overall quantity released for batch (b)(4).One syringe out of the 14 received was found to be out of spec.(b)(4).At this point this complaint is considered an isolated event since no issues were identified during process and no other complaints have been received from the field.No additional action is recommend for this complaint.Complaints received for this product and condition will continue to be tracked and trended.Bd (b)(4) will continue monitoring our manufacturing processes to ensure product quality.(b)(4).

Event Description

It was reported that a needle stick injury occurred before patient use with a 1 ml bd tb syringe with 27g x 1/2in.Bd precisionglide detachable needle that was filled with "step bacteria".The initial reported indicated that this happened because the needle cap was too tight and she had difficulty removing the cap.After the injury occurred, the clinician went to employee health where she was evaluated and received a tetanus immunization.She did not receive any lab work or any other medical interventions.

• Brand Name: 1 ML BD¿ TB SYRINGE WITH 27G X 1/2IN. 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: 6190151
• MDR Text Key: 62857855
• Report Number: 1213809-2016-00049
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 309623
• Device Lot Number: 6241524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• 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): Required Intervention