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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE: 30MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE: 30MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367729
Device Problem Leak/Splash (1354)
Patient Problem Laceration(s) (1946)
Event Date 08/01/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.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 that an unspecified number of bd vacutainer® sodium fluoride: 30mg blood collection tubes experienced a cracked tube with the tube shattering prior to use.Device operator required stitches as a result of the tube shattering.The following information was provided by the initial reporter: material no.367729 batch no.8303642.Customer stated - the tube shattered in one of the lab techs hand and they were hurt.They opened the whole case and found cracks in the tubes.Customer confirmed that the lab received 2 cases of grey top tubes.The pathology assistant used several tubes out of the package and when she pulled the top off of one it shattered in her hand.She had to get stitches in her hand, and will be out of the office until the beginning of next week.The lab opened up other packages in the cases and found at least 1 tube with a crack.Due to the injury, all damaged product was disposed because it was not approved for use and photos cannot be provided.Several employees witnessed the incident.There is currently 1 open package within the case.The customer stated this has never happened in the past.
 
Event Description
It was reported that an unspecified number of bd vacutainer® sodium fluoride: 30mg blood collection tubes experienced a cracked tube with the tube shattering prior to use.Device operator required stitches as a result of the tube shattering.The following information was provided by the initial reporter: material no.367729 batch no.8303642.Customer stated - the tube shattered in one of the lab techs hand and they were hurt.They opened the whole case and found cracks in the tubes.Customer confirmed that the lab received 2 cases of grey top tubes.The pathology assistant used several tubes out of the package and when she pulled the top off of one it shattered in her hand.She had to get stitches in her hand, and will be out of the office until the beginning of next week.The lab opened up other packages in the cases and found at least 1 tube with a crack.Due to the injury, all damaged product was disposed because it was not approved for use and photos cannot be provided.Several employees witnessed the incident.There is currently 1 open package within the case.The customer stated this has never happened in the past.
 
Manufacturer Narrative
Investigation: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.
 
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Brand Name
BD VACUTAINER® SODIUM FLUORIDE: 30MG BLOOD COLLECTION TUBES
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
MDR Report Key8905413
MDR Text Key154699844
Report Number1917413-2019-01925
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903677295
UDI-Public50382903677295
Combination Product (y/n)N
PMA/PMN Number
K945952
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 08/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2020
Device Catalogue Number367729
Device Lot Number8303642
Date Manufacturer Received08/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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