MAUDE Adverse Event Report: BECTON DICKINSON BD MICROTAINER® CONTACT-ACTIVATED LANCET; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number	366594
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 medical device lot #: b3d51h7 was reported, however, this is not a lot number manufactured for the reported catalog number.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.The manufacturing location for this product is htl.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that after using one (1) bd microtainer® contact-activated lancet, the patient developed an infection requiring hospitalization.No adverse impact was reported regarding the patient or user.Reported: "the patient developed infection after using needle 366594, lot no b3d51h7 admitted to hospital on (b)(6) 2025.The patient was admitted with right middle finger cellulitis following a finger prick test at home.He was treated with iv antibiotics and hand elevation and discharged.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 14-aug-2025.Investigation summary "bd received 6 samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for infection with the incident lot was not observed.Additionally, retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to infection as all samples met specifications.Sterilization records were also reviewed, and no deviations were found.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode infection.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.".
Event or Problem Description
It was reported that after using one (1) bd microtainer® contact-activated lancet, the patient developed an infection requiring hospitalization.No adverse impact was reported regarding the patient or user.Reported verbatim: "the patient developed infection after using needle 366594, lot no b3d51h7 admitted to hospital on (b)(6) 2025.The patient was admitted with right middle finger cellulitis following a finger prick test at home.He was treated with iv antibiotics and hand elevation and discharged.".

• Brand Name: BD MICROTAINER® CONTACT-ACTIVATED LANCET
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22649018
• Report Number: 2243072-2025-00933
• Device Sequence Number: 8632558
• Product Code: FMK
• UDI-Device Identifier: 30382903665946
• UDI-Public: (01)30382903665946
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K223243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: 366594
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown