MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367874
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9220473, medical device expiration date: 2021-08-31, device manufacture date: 2019-08-08, medical device lot #: 9344985, medical device expiration date: 2021-12-31, device manufacture date: 2019-12-10.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the additive was abnormal with a bd vacutainer® sodium heparinn (nh) 158 usp units blood collection tubes.The following information was provided by the initial reporter: customer says the lab tech stated that when they are processing their samples, the tubes are gel like and hard.Additionally, on 2020-10-02 the customer provided the following additional information: after further investigation into the situation, it was determined that it was site collection error.The blood was drawn in a syringe and was clotting even before they attempted to transfer it to the vacutainer tube.
Additional Manufacturer Narrative
H6: investigation summary: bd had not received samples or photos for evaluation.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.The customer indicated that it appeared to be caused by a collection error.
Event or Problem Description
It was reported that the additive was abnormal with a bd vacutainer® sodium heparinn (nh) 158 usp units blood collection tubes.The following information was provided by the initial reporter: customer says the lab tech stated that when they are processing their samples, the tubes are gel like and hard.Additionally, on 2020-10-02 the customer provided the following additional information: after further investigation into the situation, it was determined that it was site collection error.The blood was drawn in a syringe and was clotting even before they attempted to transfer it to the vacutainer tube.

• Brand Name: BD VACUTAINER SODIUM HEPARINN (NH) 158 USP UNITS 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: 10708285
• Report Number: 1917413-2020-00968
• Device Sequence Number: 14286826
• Product Code: JKA
• UDI-Device Identifier: 50382903678742
• UDI-Public: 50382903678742
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 367874
• Device Catalogue Number: 367874
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1