MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367671
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0044108, medical device expiration date: 2021-08-31, device manufacture date: 2020-02-13.Medical device lot #: 0100247, medical device expiration date: 2021-10-31, device manufacture date: 2020-04-09.Medical device lot #: 0258300, medical device expiration date: 2022-03-31, device manufacture date: 2020-09-14.Medical device lot #: 1014062, medical device expiration date: 2022-07-31, device manufacture date: 2021-01-14.Medical device lot #: 9344922, medical device expiration date: 2021-06-30, 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.
Event or Problem Description
It was reported when using the bd vacutainer® sodium heparinn (nh) 33 usp = 33 iu blood collection tubes, the device experienced clotting / micro clots.The following information was provided by the initial reporter.The customer stated: i received a call from a customer calling from (b)(6).She stated that one of the studies they¿re running they are seeing really high clotting rates in particular for sodium heparin tubes.13 samples were affected between early (b)(6).
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos for evaluation.Therefore, retention samples of the incident lots were selected from bd inventory for evaluation and upon completion, no issues relating to clotting were observed.Retention samples were visually inspected, with no issues identified.Retention samples were further evaluated through a clinical study: no difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure (clotting) because the defect was not evident in the testing of the complaint lot samples.All visual observations of both retain and control samples tested demonstrated clinically acceptable performance.The tubes performed as expected.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 unconfirmed for clotting.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
Event or Problem Description
It was reported when using the bd vacutainer® sodium heparinn (nh) 33 usp = 33 iu blood collection tubes, the device experienced clotting / micro clots.The following information was provided by the initial reporter.The customer stated: i received a call from a customer calling from lab corp in geneva, switzerland.She stated that one of the studies they¿re running they are seeing really high clotting rates in particular for sodium heparin tubes.13 samples were affected between early april to june.

• Brand Name: BD VACUTAINER® SODIUM HEPARINN (NH) 33 USP = 33 IU BLOOD COLLECTION TUBE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12186230
• Report Number: 1917413-2021-00638
• Device Sequence Number: 936869
• Product Code: JKA
• UDI-Device Identifier: 50382903676717
• UDI-Public: 50382903676717
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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: 367671
• Device Catalogue Number: 367671
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 07/17/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown