MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE COMPLETE CUP KIT; TRANSPORT CULTURE MEDIUM

Model Number	364956
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® urine complete cup kits, the device experienced dry soap towelettes.This event occurred 50 times.The following information was provided by the initial reporter.The customer stated: it was reported that their are cuts inside the kits that are making the wipes dry, therefor defective." one of the northside departments opened a kit and the wipe inside the kit has a cut package.She said appears that all of the kits in her case are defective.This has resulted in the wipes being dry.The outside of the product has not been compromised, so it appears to have happened at the manufacturing level." complaint rationale ¿ based on the information provided, our conclusion is that the device cited meets our criteria of a complaint ¿refer to complaint determination decision tree (nassc-rcc-007).
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 when using the bd vacutainer® urine complete cup kits, the device experienced dry soap towelettes.This event occurred 50 times.The following information was provided by the initial reporter.The customer stated: it was reported that their are cuts inside the kits that are making the wipes dry, therefor defective." one of the northside departments opened a kit and the wipe inside the kit has a cut package.She said appears that all of the kits in her case are defective.This has resulted in the wipes being dry.The outside of the product has not been compromised, so it appears to have happened at the manufacturing level." complaint rationale ¿ based on the information provided, our conclusion is that the device cited meets our criteria of a complaint ¿refer to complaint determination decision tree (nassc-rcc-007).
Additional Manufacturer Narrative
H6: investigation summary: bd had not received samples or photos for investigation.Therefore, ten (10) retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to open wipe packages/dry wipes 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 notifications.This complaint is unable to be confirmed for the indicated failure mode of open wipe packages/dry wipes based on the retention samples.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER® URINE COMPLETE CUP KIT
• Common Device Name: TRANSPORT CULTURE MEDIUM
• 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: 13458798
• Report Number: 1917413-2022-00051
• Device Sequence Number: 20047196
• Product Code: JSM
• UDI-Device Identifier: 50382903649568
• UDI-Public: 50382903649568
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K024240
• 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): 02/24/2022

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 Expiration Date: 05/31/2023
• Device Model Number: 364956
• Device Catalogue Number: 364956
• Device Lot Number: 1302301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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