MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE: 30MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367729
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE: 30MG BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8905413
• Report Number: 1917413-2019-01925
• Device Sequence Number: 2549119
• Product Code: JKA
• UDI-Device Identifier: 50382903677295
• UDI-Public: 50382903677295
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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
• Operator of Device: Other
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 367729
• Device Lot Number: 8303642
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other