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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 25 G X 5/8 IN. BD PRECISIONGLIDE¿ DETACHABLE NEEDLE TUBERCULIN SYRINGE AND NEEDLE

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BECTON DICKINSON MEDICAL SYSTEMS 1 ML BD¿ TB SYRINGE WITH 25 G X 5/8 IN. BD PRECISIONGLIDE¿ DETACHABLE NEEDLE TUBERCULIN SYRINGE AND NEEDLE Back to Search Results
Catalog Number 309626
Device Problems Detachment Of Device Component (1104); Contamination (1120); Device Damaged Prior to Use (2284)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: sample evaluation: one open 1ml packaged syringe with needle was received by bd (b)(4) and confirmed to be from batch #7215560 (p/n 309626). The sample was visually evaluated. The syringe was found to have liquid drops in the fluid path. The liquid drops appear to be reddish in tint. The sample was sent for ftir evaluation to flks. The sample was examined and exhibited dark liquid droplets on the surface of the barrel tip and on the inner surface of the hub. A few minutes after removing the needle from the barrel, the dark liquid droplets crystallized and formed solid material. As per request, a small portion of this material was removed from the sample and prepared for ftir spectral analysis. The spectral analysis shows that the material is most likely a type of medication (carboxymethylcellulose sodium salt and a glycol derivative shown for comparison). Based on the sample evaluation, the fluid observed cannot be confirmed to have originated during the manufacturing process. It appears that the sample had been manipulated prior to its return for evaluation. Dhr review for batch 7215560 (p/n 309626): manufacturing date: 08/04/2017 to 08/05/2017. Batch quantity was (b)(4). All visual inspections were performed as per requirement with no quality notifications related to the complaint defect. Batch 7215560 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment. Investigation conclusion: root cause and capa not required as not defects were confirmed.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported by a consumer that she had an issue with "contaminated" fluid in a 1 ml bd¿ tuberculin syringe with 25 g x 5/8 in. Bd precisionglide¿ detachable needle. The issue was found prior to use. There was no report of injury or medical intervention.
 
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Brand Name1 ML BD¿ TB SYRINGE WITH 25 G X 5/8 IN. BD PRECISIONGLIDE¿ DETACHABLE NEEDLE
Type of DeviceTUBERCULIN SYRINGE AND NEEDLE
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 Key7187695
MDR Text Key264314540
Report Number1213809-2017-00437
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 other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2022
Device Catalogue Number309626
Device Lot Number7215560
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2017
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: 01/12/2018 Patient Sequence Number: 1
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