MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	364960
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: preamendment.Device expiration date: unknown.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd vacutainer® blood collection tubes for microbiological study experienced a cracked tube, leakage, and blood pooling in the stopper well after use.The following information was provided by the initial reporter: material no.364960 batch no.Unknown on 7/16/2019- reached out to customer via phone to clarify complaint information: customer stated they received the package with the broken shipment and stated they have previously received boxes like this but have not reported the problem and is unaware of dates of event or lots affected.Customer also stated for the incident on (b)(6) 2019 (one of the nurses put the label on and the tube started leaking around the top near the edge/where the yellow stopper goes) she is unaware of the lot number, no adverse events.Email: the research facility quality assurance team called the customer and the customer stated that yesterday ((b)(6) 2019), they used the product to draw a patient¿s blood.One of the nurses put the label on and the tube started leaking around the top near the edge/where the yellow stopper goes.The customer does not know which lot or shipment it came from.Allegation: customer was drawing blood and the tube exploded breaking the glass into fragments on the nurse and spilling the blood on her.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.As there was no sample or photo available for evaluation, a root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd vacutainer® blood collection tubes for microbiological study experienced a cracked tube, leakage, and blood pooling in the stopper well after use.The following information was provided by the initial reporter: material no.364960 batch no.Unknown.7/16/2019- reached out to customer via phone to clarify complaint information: customer stated they received the package with the broken shipment and stated they have previously received boxes like this but have not reported the problem and is unaware of dates of event or lots affected.Customer also stated for the incident on 7/11/2019 (one of the nurses put the label on and the tube started leaking around the top near the edge/where the yellow stopper goes) she is unware of the lot number, no adverse events.Email: the research facility quality assurance team called the customer and the customer stated that yesterday ((b)(6) 2019), they used the product to draw a patient¿s blood.One of the nurses put the label on and the tube started leaking around the top near the edge/where the yellow stopper goes.The customer does not know which lot or shipment it came from.Allegation: customer was drawing blood and the tube exploded breaking the glass into fragments on the nurse and spilling the blood on her.

• Brand Name: BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES
• 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: 8845880
• Report Number: 1917413-2019-01837
• Device Sequence Number: 10845043
• Product Code: JKA
• UDI-Device Identifier: 50382903649605
• UDI-Public: 50382903649605
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• 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): 08/09/2019

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: Health Professional
• Device Catalogue Number: 364960
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/09/2019
• 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