MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. KIT GRP A STREP 30 TEST VERITOR; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Model Number 256040

Device Problem Break (1069)

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

Event Date 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown, device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that while using kit grp a strep 30 test veritor the customer faced a minimum 3 different events where the swab tip came off when using the swabs on patients.This event occurred 3 times.The following information was provided by the initial reporter: "the customer faced a minimum 3 different events where the swab tip came off when using the swabs on patients".

Event Description

It was reported that while using kit grp a strep 30 test veritor the customer faced a minimum 3 different events where the swab tip came off when using the swabs on patients.This event occurred 3 times.The following information was provided by the initial reporter: "the customer faced a minimum 3 different events where the swab tip came off when using the swabs on patients".

Manufacturer Narrative

H.6 investigation summary: this statement is to summarize the investigation results regarding the complaint that alleges " swab tip came off when using the swabs on patients" while using kit grp a strep 30 test veritor (material # 256040), batch number unknown.Bd quality performs a systematic approach to investigate broken swab complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation and testing were not performed because the batch number is unknown.The reported issue was unable to be confirmed.The root cause could not be identified.No trend against broken/damage swabs was identified.Currently no adverse trend for broken/damage swabs identified.Bd quality will continue to closely monitor for trends.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.

• Brand Name: KIT GRP A STREP 30 TEST VERITOR
• Type of Device: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15161274
• MDR Text Key: 297449786
• Report Number: 3006948883-2022-00162
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 00382902560401
• UDI-Public: 00382902560401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122718
• 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: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 256040
• Device Catalogue Number: 256040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• 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