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	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical 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 during the blood draw, the bd vacutainer® blood collection tube for microbiological studies cracked while putting the stopper in and broke, causing blood to go "everywhere".The nurse was reportedly wearing gloves and was not injured by the broken glass nor exposed to the blood spilt on her.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "the customer stated they received the one pack of 100, some of which were broken.Normally, they just take out the broken ones and keep the rest.The customer stated that the day before they received this broken shipment, one of the nurses was drawing blood using the same product, and when the nurse was putting the stopper in, the tube was cracked on the top and broke, and blood went everywhere.The customer confirmed that the nurse was not injured and no additional medical attention was required.The nurse was wearing gloves.".
Additional Manufacturer Narrative
H.6.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 during the blood draw, the bd vacutainer® blood collection tube for microbiological studies cracked while putting the stopper in and broke, causing blood to go "everywhere".The nurse was reportedly wearing gloves and was not injured by the broken glass nor exposed to the blood spilt on her.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "the customer stated they received the one pack of 100, some of which were broken.Normally, they just take out the broken ones and keep the rest.The customer stated that the day before they received this broken shipment, one of the nurses was drawing blood using the same product, and when the nurse was putting the stopper in, the tube was cracked on the top and broke, and blood went everywhere.The customer confirmed that the nurse was not injured and no additional medical attention was required.The nurse was wearing gloves.".

• 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: 8836538
• Report Number: 1917413-2019-01816
• Device Sequence Number: 19461777
• 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: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• 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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 07/29/2019
• 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