MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER¿ 24 HOUR URINE SPECIMEN CONTAINER; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 364982

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd vacutainer¿ 24 hour urine specimen container, the device experienced a broken lid/cap.The following information was provided by the initial reporter.The customer stated: since the commissioning of this reference, a brittleness has been noted at the level of the top of the jar and the screw thread of closing.This brittleness is noted after the first use in a bedpan washer.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos from the customer for evaluation.Additionally, 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.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

Since the commissioning of this reference, a brittleness has been noted at the level of the top of the jar and the screw thread of closing.This brittleness is noted after the first use in a bedpan washer.The jar can sometimes be used a second time without any major risk for the carers, but must be discarded after the second use.The defect observed is independent of the batch number of the device.For information, the highest temperature reached during disinfection in the bedpan washer is 94° c.There is no drying phase.

• Brand Name: BD VACUTAINER¿ 24 HOUR URINE SPECIMEN CONTAINER
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13743648
• MDR Text Key: 290393817
• Report Number: 2243072-2022-00337
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

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
• Device Operator: Other
• Device Catalogue Number: 364982
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/12/2022
• Supplement Dates Manufacturer Received: 05/02/2022
• Supplement Dates FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1