MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD KIT CRYSTAL GP ID; GRAM POSITIVE IDENTIFICATION PANEL

Catalog Number 24514035

Device Problem Leak/Splash (1354)

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

Event Date 10/22/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.There is no 510(k) for this device as it is manufactured outside the us and not sold in the us but is considered to be substantially similar to the legally u.S.Marketed device bd (b)(6) positive id system catalog number 245140 which has 510k number (b)(4).

Event Description

It was reported that while using bd kit (b)(6) a patient sample leak was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: according to the customer¿s report, when bacterial liquid is poured onto the base, the liquid leaks.".

Manufacturer Narrative

H.6.Investigation: this complaint is for a leaking base of crystal gp id kit (24514035) batch number unknown.No photos or product returns were provided for investigation.Due to the batch number being unknown, no retention investigation could be completed and this complaint is not confirmed.A review of quality notification could not be performed as the batch number is unknown.A review of complaints could not be completed as the batch number is unknown.Complaint trending was performed and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.Please continue to communicate any additional concerns.H3 other text : see h.10.

Event Description

It was reported that while using bd kit crystal gp id a patient sample leak was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: " according to the customer¿s report, when bacterial liquid is poured onto the base, the liquid leaks.".

• Brand Name: BD KIT CRYSTAL GP ID
• Type of Device: GRAM POSITIVE IDENTIFICATION PANEL
• 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: 12849251
• MDR Text Key: 285355361
• Report Number: 1119779-2021-01868
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961968
• 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: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 24514035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• 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