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

Model Number 220215

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 04/18/2023

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.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot#: 2209244, d4.Medical device expiration date: 31-may-2027, h4.Device manufacture date: 13-jul-2022.D4.Medical device lot#: 2209246, d4.Medical device expiration date: 31-may-2027, h4.Device manufacture date: 13-jul-2022.

Event Description

It was reported that the certificated for bd calibrated disposable inoculating loops, green 1l (20x50 loops) have the incorrect lot information on them.The following information was provided by the initial reporter: customer is requesting the certificates for lot #s 2209244 and 2209246.The certificates originally received have the incorrect lot #s on them.

Manufacturer Narrative

H.6 investigation summary: event description: " customer is requesting the certificates for lot #s 2209244 and 2209246.The certificates originally received have the incorrect lot #s on them." 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 the certificated for bd calibrated disposable inoculating loops, green 1 l (20x50 loops) have the incorrect lot information on them.The following information was provided by the initial reporter: customer is requesting the certificates for lot #s 2209244 and 2209246.The certificates originally received have the incorrect lot #s on them.

• 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 & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16942900
• MDR Text Key: 315873678
• Report Number: 1119779-2023-00566
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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