MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367835
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the caps are loose prior to use with 100 bd vacutainer® edta (k2e) 5.4mg blood collection tubes.The following information was provided by the initial reporter: the cap loose.
Additional Manufacturer Narrative
H.6.Investigation: bd received 1 shelf pack of samples and 4 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for damaged tray with the incident lot was observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for damaged tray with the incident lot was observed as all product specifications were met.Additionally, 10 customer samples were evaluated by water fill testing and the indicated failure mode for stopper pull out with the incident lot was not observed as all product specifications were met.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 non-conformances during manufacturing of the product.
Event or Problem Description
It was reported that the caps are loose prior to use with 100 bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes.The following information was provided by the initial reporter: the cap loose.

• Brand Name: BD VACUTAINER K2 EDTA (K2E) 5.4MG 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: 10560903
• Report Number: 1917413-2020-00840
• Device Sequence Number: 3161493
• Product Code: GIM
• UDI-Device Identifier: 50382903678353
• UDI-Public: 50382903678353
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K981013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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 Expiration Date: 05/31/2021
• Device Model Number: 367835
• Device Catalogue Number: 367835
• Device Lot Number: 0009604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/06/2020
• 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