MAUDE Adverse Event Report: BECTON DICKINSON TUBE EDTA PLH 13X75 3.0 PLBL LAV BC; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	368054
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported the tube edta plh 13x75 3.0 plbl lav bc experienced under-fill or low draw of a tube with blood during use.The following information was provided by the initial reporter: the med tech was wanting information in regards to minimum and maximum draw for this product.They are experiencing low draw volume.No specific lot involved, they have noticed this is an on-going issue.Event happens over multiple lots, drawn by 22 gauge needles, butterflies are rarely used, upon receipt of tubes are air conditioned.
Event or Problem Description
It was reported the tube edta plh 13x75 3.0 plbl lav bc experienced under-fill or low draw of a tube with blood during use.The following information was provided by the initial reporter: the med tech was wanting information in regards to minimum and maximum draw for this product.They are experiencing low draw volume.No specific lot involved, they have noticed this is an on-going issue.Event happens over multiple lots, drawn by 22 gauge needles, butterflies are rarely used, upon receipt of tubes are air conditioned.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples, but 1 photos were provided by the customer for investigation.The photos were reviewed and the indicated failure mode for underfill with the incident lot was not observed.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.H3 other text : see h.10.

• Brand Name: TUBE EDTA PLH 13X75 3.0 PLBL LAV BC
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10276799
• Report Number: 2243072-2020-01065
• Device Sequence Number: 2912555
• Product Code: JKA
• UDI-Device Identifier: 50382903680547
• UDI-Public: 50382903680547
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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 Model Number: 368054
• Device Catalogue Number: 368054
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 07/22/2020
• 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