MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® QUIKHEEL¿ PREEMIE LANCET; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number	368100
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd microtainer® quikheel¿ preemie lancet there was incorrect label information of three labels.Three lot numbers were affected.Therre was no report of patient impact."when the barcodes on the case barcode label of the lots (cat#368100/lot#2259018, 2259021, 2291751) were read by keyence scanners, it was possible to read them, but the lot number and the expiration date were determined incorrectly.After checking the read barcode information, it was considered that the barcode could not be identified correctly because an illegal character "!" or "t" was entered at the end of the barcode number.".
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot#: 2259018 d4.Medical device expiration date: 31-08-2027 h4.Device manufacture date: 27-10-2022, d4.Medical device lot#: 2259021 d4.Medical device expiration date: 31-08-2027 h4.Device manufacture date: 27-10-2022, d4.Medical device lot#: 2291751 d4.Medical device expiration date: 30-09-2027 h4.Device manufacture date: 27-10-2022, 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 or Problem Description
It was reported that while using bd microtainer® quikheel¿ preemie lancet there was incorrect label information of three labels.Three lot numbers were affected.Therre was no report of patient impact."when the barcodes on the case barcode label of the lots (cat#368100/lot#2259018, 2259021, 2291751) were read by keyence scanners, it was possible to read them, but the lot number and the expiration date were determined incorrectly.After checking the read barcode information, it was considered that the barcode could not be identified correctly because an illegal character "!" or "t" was entered at the end of the barcode number.".
Additional Manufacturer Narrative
H.6 investigation summary "material #: 368100.Lot/batch #: 2259018, 2259021, 2291751.Bd had not received samples, but 12 photos were provided for investigation.The photos were reviewed and the indicated failure mode for incorrect barcode with the incident lot was not observed.Additionally, retention samples from bd inventory of each reported lot number were evaluated by visual examination and functional testing, each having their barcodes scanned, and no issues were observed relating to incorrect barcode as all samples met specifications.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 incorrect barcode.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.".

• Brand Name: BD MICROTAINER® QUIKHEEL¿ PREEMIE LANCET
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17299205
• Report Number: 2618282-2023-00054
• Device Sequence Number: 17100579
• Product Code: FMK
• UDI-Device Identifier: 50382903681001
• UDI-Public: 50382903681001
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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
• Operator of Device: Other
• Device Model Number: 368100
• Device Catalogue Number: 368100
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown