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

Catalog Number	367001
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg investigation summary: bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer's indicated failure mode for the shelf pack labeled as retention samples with the incident lot was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Root cause description: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the foam tray had "retention" written on it with a bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg.This occurred with 100 tubes in 1 shelf pack and was discovered prior to use.The following information was provided by the initial reporter: foam tray has "retention" written on it under the plastic wrap.
Event or Problem Description
It was reported that the foam tray had "retention" written on it with a bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg.This occurred with 100 tubes in 1 shelf pack and was discovered prior to use.The following information was provided by the initial reporter: foam tray has "retention" written on it under the plastic wrap.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: h.3 reason code for no evaluation: other.H.3.If other specify: see h.10.

• 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: 8928272
• Report Number: 1917413-2019-01968
• Device Sequence Number: 16762154
• Product Code: JKA
• UDI-Device Identifier: 50382903670012
• UDI-Public: 50382903670012
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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 Expiration Date: 04/30/2021
• Device Catalogue Number: 367001
• Device Lot Number: 9095732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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