MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Model Number 442020

Device Problem False Positive Result (1227)

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

Event Date 06/06/2022

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.Medical device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported that while using bd bactec¿ peds plus¿/ f culture vials (plastic) the customer was complaining for false positive pediatric vial, lot no.1294782, this bottle also false positive for proteus in blood culture bottles.The following information was reported "the customer indicates, no gram stain prior to make molecular test, no observable defect on the bottles, or extreme ambient conditions prior to use.These vials were purchased directly to bd, quantity pending to confirmation.

Manufacturer Narrative

H.6.Investigation summary catalog 442020; batch no.1294782.Customer reported false positive result.Neither photos nor returned good samples were received.Upon further evaluation it was noticed that complaint received was from a product already expired.Investigation cannot be conducted to the retention samples since the product is already expired.A complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.The batch history record could not be reviewed as the lot is expired, nonetheless batch history records are always reviewed prior to product release.Users are cautioned in the package insert under limitation of the procedure: ¿a gram-stained smear from culture medium may contain small number of non-viable organisms derived from media constituents, staining reagents, immersion oil, glass slide and specimens used for inoculation.There are many factors that can influence the false positive rate, including blood volume, blood cell counts, environmental factors, and media lot to lot variations.Complaint is unconfirmed.No corrective actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.H3 other text : see h.10.

Event Description

It was reported that while using bd bactec¿ peds plus¿/ f culture vials (plastic) the customer was complaining for false positive pediatric vial, lot no.1294782, this bottle also false positive for proteus in blood culture bottles.The following information was reported "the customer indicates, no gram stain prior to make molecular test, no observable defect on the bottles, or extreme ambient conditions prior to use.These vials were purchased directly to bd, quantity pending to confirmation.

• Brand Name: BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)
• Type of Device: SYSTEM, BLOOD CULTURING
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15291219
• MDR Text Key: 304797437
• Report Number: 1119779-2022-01137
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420208
• UDI-Public: 00382904420208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 442020
• Device Catalogue Number: 442020
• Device Lot Number: 1294782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2022
• 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