MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367925
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device brand name: bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tubes.Medical device expiration date: unknown.Pma 510(k)#: k945952, k901449.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
Material no: 367925, batch no: unknown.It was reported that before use of the bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tubes the side of the tubes appeared cloudy, possibly from the power sticking to the side of the tubes.The following information was provided by the initial reporter: customer stated that the tubes appear cloudy which is not normal."customer states that she has never seen the tubes look like this.Because all the tubes in their inventory looked the same they were passed by the qc department and put into kits.The tubes appear to have a heavy film on the inside and she is just inquiring if this is normal because she has never seen the tubes look like this.Customer did not consider this a complaint but explained that according to our process it would fall under our complaint handling procedure.
Additional Manufacturer Narrative
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.
Event or Problem Description
Material no: 367925 batch no: unknown it was reported that before use of the bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tubes the side of the tubes appeared cloudy, possibly from the power sticking to the side of the tubes.The following information was provided by the initial reporter: customer stated that the tubes appear cloudy which is not normal."customer states that she has never seen the tubes look like this.Because all the tubes in their inventory looked the same they were passed by the qc department and put into kits.The tubes appear to have a heavy film on the inside and she is just inquiring if this is normal because she has never seen the tubes look like this.Customer did not consider this a complaint but explained that according to our process it would fall under our complaint handling procedure.

• Brand Name: SEE H.10
• 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: 9032723
• Report Number: 1917413-2019-02067
• Device Sequence Number: 410382
• Product Code: JKA
• UDI-Device Identifier: 50382903679251
• UDI-Public: 50382903679251
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• 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): 09/19/2019

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: Other
• Device Catalogue Number: 367925
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 09/19/2019
• 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