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

Catalog Number	368101
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd microtainer® quikheel¿ lancet there was missing label information.The following information was provided by the initial reporter.The customer stated: "the searched sample of lot 1222506 does not present instructions for use.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd microtainer® quikheel¿ lancet there was missing label information.The following information was provided by the initial reporter.The customer stated: "the searched sample of lot 1222506 does not present instructions for use.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos for evaluation.Therefore, 1 retention sample from bd inventory was evaluated by visual examination and the issue relating to missing instruction for use (ifu) insert was not observed as this product does not require the addition of an ifu insert as part of the manufacturing process.The retain sample was inspected for packaging and labeling characteristics relevant to product identification and use of the device required by manufacturing procedures.All tests had acceptable results 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.While bd was unable to confirm this complaint for the indicated failure mode missing ifu insert, bd has initiated further root cause investigation relating to the issue of missing ifu insert through corrective and preventive actions.H3 other text : see h.10.

• Brand Name: BD MICROTAINER® QUIKHEEL¿ LANCET
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15352078
• Report Number: 2618282-2022-00053
• Device Sequence Number: 5864270
• Product Code: MDM
• UDI-Device Identifier: 50382903681018
• UDI-Public: 50382903681018
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: EXEMPT
• 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): 10/20/2022

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 368101
• Device Lot Number: 1222506
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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
• Patient Sex: Unknown