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

Catalog Number	368101
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo showed one (1) lancet without the original blister packaging.It was observed that the lancet trigger (white button) was partially depressed, and the blade appears to have activated but, the blade did not retract into the housing.It cannot be confirmed that the reported condition was due to manufacturing process because the sample was not in the original blister packaging.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.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 bd microtainer® quikheel¿ lancet had a retraction issue.The following information was provided by the initial reporter: "the nurse found that the needle wasn't covered by shield completely prior to use.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 11-may-2021.H6: investigation summary: bd received 1 sample and 1 photo that was provided by the customer for investigation.A review of the photo and sample revealed the lancet trigger (white button) was partially depressed, and the blade appears to have been activated but the blade did not retract into the housing.The sample was tested by visual and functional testing and the indicated failure mode for retraction failure was observed.However, it cannot be confirmed that the reported condition was due to manufacturing process because the sample was not in the original blister packaging.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.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported that bd microtainer® quikheel¿ lancet had a retraction issue.The following information was provided by the initial reporter: "the nurse found that the needle wasn't covered by shield completely prior to use".

• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11809544
• Report Number: 2618282-2021-00026
• Device Sequence Number: 11646605
• Product Code: FMK
• UDI-Device Identifier: 50382903681001
• UDI-Public: 50382903681001
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 08/10/2022

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: 01/31/2025
• Device Catalogue Number: 368101
• Device Lot Number: 0030147
• 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: 04/14/2021
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2020
• 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