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

Model Number	366480
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0289375, medical device expiration date: 2022-10-31, device manufacture date: 2020-10-15.Medical device lot #: 0316315, medical device expiration date: 2022-11-30, device manufacture date: 2020-11-11.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 when using the bd vacutainer® sodium heparin (nh) blood collection tubes, the device experienced discolored / abnormal additive form.The following information was provided by the initial reporter.The customer stated: customer reports that they are using the sodium heparin tubes and they noticed that there is crystallization at the bottom of the tube.She said it looks like a contact lens.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples, but two (2) photos were provided for investigation.The photos were reviewed and the indicated failure mode for additive abnormality with the incident lot was not observed.The photos show a pellet of freeze-dried additive in the bottom of the tube.For product catalog 366480, the sodium heparin additive is filled into the tubes and then the tubes are freeze-dried.The photos show the normal appearance of the additive after the freeze-dried process.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.This complaint is unable to be confirmed for the indicated failure mode of additive abnormality.
Event or Problem Description
It was reported when using the bd vacutainer® sodium heparin¿ (nh) blood collection tubes, the device experienced discolored / abnormal additive form.The following information was provided by the initial reporter.The customer stated: customer reports that they are using the sodium heparin tubes and they noticed that there is crystallization at the bottom of the tube.She said it looks like a contact lens.

• Brand Name: BD VACUTAINER SODIUM HEPARIN (NH) 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: 12284459
• Report Number: 1917413-2021-00705
• Device Sequence Number: 14803237
• Product Code: JKA
• UDI-Device Identifier: 50382903664806
• UDI-Public: 50382903664806
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/11/2021

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: Other
• Device Model Number: 366480
• Device Catalogue Number: 366480
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1