MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 15.8 MG; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	362799
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for defective stopper molding with the incident lot was observed.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.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that prior to use with bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg the cap was discovered to be cracked.The following information was provided by the initial reporter: customer found one ppt tube which has a crack on its hemogard cap.
Event or Problem Description
It was reported that prior to use with bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg the cap was discovered to be cracked.The following information was provided by the initial reporter: customer found one ppt tube which has a crack on its hemogard cap.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for defective stopper molding with the incident lot was observed.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.The retention samples were inspected with no issues being identified.H3 other text : see h.10.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-02-23.H6: investigation summary: bd had received 1 sample and 2 photos for investigation.The photos were reviewed and the indicated failure mode for defective stopper molding with the incident lot was observed.The customer samples were evaluated by visual examination and the indicated failure mode of defective stopper molding with the incident lot was observed.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.H3 other text : see h10.
Event or Problem Description
It was reported that prior to use with bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg the cap was discovered to be cracked.The following information was provided by the initial reporter: customer found one ppt tube which has a crack on its hemogard cap.

• Brand Name: BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 15.8 MG
• 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: 11314383
• Report Number: 1917413-2021-00085
• Device Sequence Number: 11447409
• Product Code: JKA
• UDI-Device Identifier: 50382903627993
• UDI-Public: 50382903627993
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K972075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2021

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 Expiration Date: 09/30/2021
• Device Model Number: 362799
• Device Catalogue Number: 362799
• Device Lot Number: 0258257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 02/23/2021; 04/09/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 02/23/2021; 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1