MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD CALIBRATED DISPOSABLE INOCULATING LOOPS, GREEN 1¿L (20X50 LOOPS); SEE H.10

Catalog Number 220215

Device Problem Inaccurate Information (4051)

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

Event Date 08/30/2023

Event Type  malfunction  

Manufacturer Narrative

D.3 - common device brand name: equipment, laboratory, general purpose, labeled and promoted for a specific medical use h.3.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 while using bd calibrated disposable inoculating loops, green 1l (20x50 loops) there was a labeling issue with incorrect label information.The following was provided by the initial reporter: it was reported by the customer that loops inoculating 50/tube 1 microliter certificate included in the box references a different lot/batch than the lot# of the loops.The certificate included in the box references a different lot/batch than the lot# of the loops.

Manufacturer Narrative

H.6.Investigation summary: this memo serves to summarize findings on your recent complaint (b)(4) on product 220215 (loops inoculating 50/tube 1 microliter), lot numbers 2301036, where it was observed that the lot number on the certificate wasn¿t the same as the lot number on the product packaging.Event description: " the certificate included in the box references a different lot/batch than the lot# of the loops." 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 device history record did indicate that the sub-lot was assigned as opposed to the final product lot number.Sample analysis: no photos or returns were available.An inspection of the retention samples did show the noted defect.Evaluations results: based on the investigation, the noted defect was observed in the retention sample inspection.An error in manufacturing was the cause for the wrong lot number on the certificate.Investigation conclusion: based on the evaluation of the investigation, the complaint was confirmed.A review of complaints does not indicate that a trend is present.No further action will be taken as this is considered to be an isolated incident.A corrected cert for each lot has been provided.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 a labeling issue with incorrect label information.The following was provided by the initial reporter: it was reported by the customer that loops inoculating 50/tube 1 microliter certificate included in the box references a different lot/batch than the lot# of the loops.The certificate included in the box references a different lot/batch than the lot# of the loops.

• Brand Name: BD CALIBRATED DISPOSABLE INOCULATING LOOPS, GREEN 1¿L (20X50 LOOPS)
• 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: 17752905
• MDR Text Key: 323467836
• Report Number: 1119779-2023-00997
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 00382902202158
• UDI-Public: 00382902202158
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 01/17/2024

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 Catalogue Number: 220215
• Device Lot Number: 2301036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2023
• 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