MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICRO. STUDIES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	364960
Medical Device Problem Codes	Expiration Date Error (2528); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® blood collection tubes for microbiological studies the tube was used after expiration and mixed product in a pack.The expired product event occurred 1 time.The mixed product event occurred 2 times.The following information was provided by the initial reporter.The customer stated: we "received a package with two different lot numbers and expired tubes mixed in.".
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1319186.Medical device expiration date: 2022-11-30.Device manufacture date: 2021-11-15.Medical device lot #: 0345729.Medical device expiration date: 2021-12-31.Device manufacture date: 2020-12-10.Medical device lot #: 1228964.Medical device expiration date: 2022-08-31.Device manufacture date: 2021-08-16.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 when using the bd vacutainer® blood collection tubes for microbiological studies the tube was used after expiration and mixed product in a pack.The expired product event occurred 1 time.The mixed product event occurred 2 times.The following information was provided by the initial reporter.The customer stated: we "received a package with two different lot numbers and expired tubes mixed in.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 14-jun-2022.H6: investigation summary: bd received 26 samples (22 from lot 0345729 and 4 from lot 1014045; no samples received from lots 1319186 or 1228964) and 2 photos for investigation.The samples and photos were visually evaluated.The 22 samples from lot 0345729 were loose in a bag and expired on 2021-12-31.The 4 samples from lot 1014045 were wrapped in a rubber band and expired on 2022-01-31.No samples were received from lots 1319186 or 1228964.The first picture shows tubes in a shelf pack tray that is missing its shrink wrap.Both lot numbers 1319186 and 1228964 are seen in the tray.The second picture shows two shelf packs.The top shelf pack is shrink wrapped and labeled with lot 1319186 expiring 2022-11-30.The bottom shelf pack is not shrink wrapped and the lot number of the tubes cannot be observed.Evaluation of the samples received do show that lots 0345729 and 1014045 are expired; however, does not show mixed product.Tubes are not to be used past there expiration date printed on the see-through label.Evaluation of the photos received does show that lot 1319186 and 1228964 is mixed in an unwrapped shelf pack tray.However, these two lots were manufactured 2 months apart and no tubes would have remained on the line to be mixed.Additionally, the retention samples from bd inventory for all reported lots, were evaluated by visual examination and no issues were observed relating to mixed product as all samples met specifications.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 is unable to be confirmed for the indicated failure mode mixed product.Tubes should not be used past their expiration date.Bd makes no claims on the use of expired product.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h10.

• Brand Name: BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICRO. STUDIES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14940064
• Report Number: 1917413-2022-00368
• Device Sequence Number: 6196027
• Product Code: JKA
• UDI-Device Identifier: 50382903649605
• UDI-Public: 50382903649605
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 07/18/2022

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: 364960
• Device Catalogue Number: 364960
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown