MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER SERUM BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	366668
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	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported the bd vacutainer® serum blood collection tubes experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "customer called in to reported issues of under-filling.She stated there is little to no vacuum.No date of event, no specific number of occurrences, no erroneous results and no medical intervention.Customer confirmed unused samples are available for investigation.(b)(6), - "spoke with the customer.She stated that all 35 tubes in this lot have had little or no vacuum at all, when using a straight needle.They are now using different lot #s and are not seeing any vacuum issues.She will send in samples.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 3/1/2021.H.6.Investigation: bd received 64 samples of material 366668, batch 0121033 for investigation.Four samples were evaluated by visual examination and 60 samples were evaluated by draw testing and the indicated failure mode for low draw volume 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 issues during manufacturing of the product.Bd was not able to identify a root cause for the indicated failure mode.All retention samples met specification requirement when tested.
Event or Problem Description
It was reported the bd vacutainer® serum blood collection tubes experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "customer called in to reported issues of under-filling.She stated there is little to no vacuum.No date of event, no specific number of occurrences, no erroneous results and no medical intervention.Customer confirmed unused samples are available for investigation.24-feb-2021: bd tech barbara carson, - "spoke with the customer.She stated that all 35 tubes in this lot have had little or no vacuum at all, when using a straight needle.They are now using different lot #s and are not seeing any vacuum issues.She will send in samples.".

• Brand Name: BD VACUTAINER SERUM BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 11499563
• Report Number: 1024879-2021-00182
• Device Sequence Number: 17446018
• Product Code: JKA
• UDI-Device Identifier: 50382903666688
• UDI-Public: 50382903666688
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: BK050036
• 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,Followup
• Report Date (Section B): 03/22/2021

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: 08/31/2021
• Device Model Number: 366668
• Device Catalogue Number: 366668
• Device Lot Number: 0121033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1