MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH); BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	368056
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.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.To assure a high quality specimen when utilizing heparin plasma, several factors are key.Included, but not limited to are: proper phlebotomy technique to minimize poor barrier separation and platelet activation, proper tube fill volume to assure the proper blood-to-additive ration, gentle and thorough mixing, proper centrifugation conditions-g force and time, and storage conditions.Recommendations for centrifugation include setting refrigerated centrifuges at 25°c (77°f).
Event or Problem Description
It was reported that poor separation occurred after use with a bd vacutainer® pst¿ gel and lithium heparinn (lh) 56 units blood collection tubes.The following information was provided by the initial reporter, "it was reported there are issues when centrifuging gel tubes in a refrigerated centrifuge." 10 occurrences were reported, but the dates/times were not given.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH)
• 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: 8947389
• Report Number: 1917413-2019-02006
• Device Sequence Number: 11362671
• Product Code: JKA
• UDI-Device Identifier: 50382903680561
• UDI-Public: 50382903680561
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 08/15/2019

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: 368056
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 08/29/2019
• 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