MAUDE Adverse Event Report: BECTON DICKINSON BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML, FLOCKED FLEXIBLE MINITIP; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Model Number 220531

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.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.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using 30 bd¿ universal viral transport kit, 3 ml, flocked flexible minitips sample leakage was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: " customer problem: customer reports leaking 220531 tubes after specimen collection.".

Manufacturer Narrative

H.6.Investigation: this statement serves to summarize findings on the recent complaint on product 220531 (kit uvt 3ml with flocked flex minitip), lot number n10175600, where it was observed that the media was leaking from the tube.Event description: " customer reports 220531 swab tubes, lot n10175600, are leaking after specimen collection." complaint history review: a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.Device history record review: a review of the device history record did not indicate any manufacturing issues.Sample analysis: the photos did not show the noted defect.The retention samples did not exhibit any defects.Evaluations results: based on the investigation, no defect was observed.No complaint trend was present on this issue.However, bd will continue to monitor for trending.Investigation conclusion: based on the evaluation of the investigation, the complaint was not confirmed.No further actions will be taken as no confirmed defect has been identified.

Event Description

It was reported that while using 30 bd¿ universal viral transport kit, 3 ml, flocked flexible minitips sample leakage was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: " customer problem: customer reports leaking 220531 tubes after specimen collection.".

• Brand Name: BD¿ UNIVERSAL VIRAL TRANSPORT KIT, 3 ML, FLOCKED FLEXIBLE MINITIP
• Type of Device: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12450949
• MDR Text Key: 271134751
• Report Number: 2243072-2021-02275
• Device Sequence Number: 1
• Product Code: JSM
• UDI-Device Identifier: 30382902205310
• UDI-Public: 30382902205310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 220531
• Device Catalogue Number: 220531
• Device Lot Number: N10175600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2021
• 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