MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) IMPROVIRAL¿ VIRAL MEDIA WITH FLOCKED SWAB

Catalog Number 8110111

Device Problem Contamination (1120)

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).Medical device expiration date: unknown.Device manufacture date: unknown.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 improviral¿ viral media with flocked swab contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "one of the tubes is visibly contaminated.".

Event Description

It was reported that while using improviral¿ viral media with flocked swab contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "one of the tubes is visibly contaminated.".

Manufacturer Narrative

H6: investigation summary: this memo serves to summarize findings on the recent complaint (b)(4) on product 8110111 (viral preservative medium 3ml 100mm tub, lot number 201228 where it was observed that there was a contaminant in the media.A review of past complaints on this product over the past 12 months does not indicate a trend on this issue.A review of the device history record does not indicate any manufacturing issues.An examination of the photos did show the noted defect.The retention samples did not exhibit any defects.Based on the investigation, the photos did show the noted defect.There is no systemic failure in the manufacturing process and the retention samples were satisfactory.As no deviations were observed in the investigation, no corrective or preventive actions are indicated at this time.However, bd will continue to monitor for trending.Based on the evaluation of the investigation, the complaint was confirmed on the photos.No further actions will be taken as no confirmed trend has been identified.A definite root cause could not be determined.H3 other text : see h10.

• Brand Name: IMPROVIRAL¿ VIRAL MEDIA WITH FLOCKED SWAB
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12328158
• MDR Text Key: 268145208
• Report Number: 1119779-2021-01386
• Device Sequence Number: 1
• Product Code: JSM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 8110111
• Device Lot Number: 201228
• 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
• 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