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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL SYSTEMS 1 ML BD¿ TB SYRINGE WITH 27G X 1/2IN. BD PRECISIONGLIDE¿ DETACHABLE NEEDLE TUBERCULIN SYRINGE Back to Search Results
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.
 
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Brand Name1 ML BD¿ TB SYRINGE WITH 27G X 1/2IN. BD PRECISIONGLIDE¿ DETACHABLE NEEDLE
Type of DeviceTUBERCULIN 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 Key6190151
MDR Text Key62857855
Report Number1213809-2016-00049
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
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 Received12/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Catalogue Number309623
Device Lot Number6241524
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/20/2016 Patient Sequence Number: 1
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