MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) TUBE LIHEP PLH 13X75 2.0 PLBL GN; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	366664
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd had not received samples, but a photo was provided for investigation.The photo was reviewed and the indicated failure mode for underfill was observed.Additionally, ten (10) retention samples from bd inventory were evaluated by functional testing and the issue of underfill was not 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.This complaint has been confirmed for the indicated failure mode of underfill.Bd was not able to identify a root cause for the indicated failure mode.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported when using the tube lihep plh 13x75 2.0 plbl gn, the device experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: it was reported that tubes are underfilling.Customer claims tubes are not filling to the white line on the label.Ed states the tubes stop filling automatically between 1-1.5ml resulting in short samples.

• Brand Name: TUBE LIHEP PLH 13X75 2.0 PLBL GN
• 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: 12568265
• Report Number: 1917413-2021-00875
• Device Sequence Number: 4094946
• Product Code: JKA
• UDI-Device Identifier: 50382903666640
• UDI-Public: 50382903666640
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2021

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: 06/30/2022
• Device Model Number: 366664
• Device Catalogue Number: 366664
• Device Lot Number: 1040910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1