MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD SWAB BBL SGL F/F; SYSTEM, TRANSPORT, ANAEROBIC

Catalog Number 212550

Device Problem Missing Information (4053)

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

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 50 bd swab bbl sgl f/f experienced missing label information.The following information was provided by the initial reporter: according to the customer's report, the document which was supposed to be affixed to the package was detached and found separately.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 1119779-2021-01547 was sent in error.According to picture received from customer, the label is not missing the insert was detached, therefore, this is not considered to be a reportable malfunction.

Event Description

It was reported that 50 bd swab bbl sgl f/f experienced missing label information.The following information was provided by the initial reporter: according to the customer's report, the document which was supposed to be affixed to the package was detached and found separately.

• Brand Name: BD SWAB BBL SGL F/F
• Type of Device: SYSTEM, TRANSPORT, ANAEROBIC
• 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: 12502877
• MDR Text Key: 275278198
• Report Number: 1119779-2021-01547
• Device Sequence Number: 1
• Product Code: JTX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 212550
• Device Lot Number: 203203800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• 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