MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) SEE H.10

Model Number 220215

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/14/2023

Event Type  malfunction  

Manufacturer Narrative

D1: medical device brand name: bd calibrated disposable inoculating loops, green 1l (20x50 loops).D2a: common device name: equipment, laboratory, general purpose, labeled and promoted for a specific medical use.H.3.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 bd calibrated disposable inoculating loops, green 1l (20x50 loops) there was mold of 25 tubes.No patient impact reported.The following information was provided by the initial reporter: "the quantity was all 25 tubes (1250 pieces) of inoculating loop found moldy.Most of the reports showed yeast, which aligns to the defect.Some were used on urine sample.".

Manufacturer Narrative

H.6.Investigation summary: complaint history review: a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.Device history record review: a review of the device history record does not indicate any manufacturing issues.Sample analysis: a review of the photos did show black matter on the plastic loop shafts.No returns were available.The retention samples did not exhibit any defects.Evaluations results: based on the investigation, the complaint was confirmed on photos.There is no systemic failure in the manufacturing process and the retention samples were satisfactory.There is no complaint trend on this issue.Investigation conclusion: based on the evaluation of the investigation, the complaint was confirmed.No further actions will be taken as no confirmed trend has been identified.This is an isolated incident.Bd will continue to monitor for trending.

Event Description

It was reported that while using bd calibrated disposable inoculating loops, green 1 l (20x50 loops) there was mold of 25 tubes.No patient impact reported.The following information was provided by the initial reporter: "the quantity was all 25 tubes (1250 pieces) of inoculating loop found moldy.Most of the reports showed yeast, which aligns to the defect.Some were used on urine sample.".

• Brand Name: SEE H.10
• Type of Device: SEE H.10
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17342769
• MDR Text Key: 319524565
• Report Number: 1119779-2023-00781
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 00382902202158
• UDI-Public: 00382902202158
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• 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: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 220215
• Device Catalogue Number: 220215
• Device Lot Number: 2209244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1