MAUDE Adverse Event Report: BECTON DICKINSON BD MICROTAINER® CONTACT-ACTIVATED LANCET

Catalog Number 366592

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/22/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is (b)(6) laboratory.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed in report and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while a health care worker was using a bd microtainer® contact-activated lancet to draw blood for a glucose control on a (b)(6) patient, the health care worker retracted lancet into their hand to throw away.At that moment, the health care worker felt the needle puncture into their finger.When removing the glove to check the puncture spot, there was a visible drop of blood.Precautionary post-exposure prophylaxis (pep) treatment and blood sampling was started immediately following the incident.Additional appointments have been scheduled to check liver values from the prescribed medication, to discuss psychosocial pressure and any side effects of the prescribed medication.(b)(6) testing will be performed once treatment ends.

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for the needle not retracting with the incident lot was not observed.Additionally, retention samples were selected from htl inventory for evaluation & testing and upon completion, no issues pertaining to the needle not retracting was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.However, the oem supplier for this device, htl, has initiated further investigation relating to this issue through a capa.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.Investigation conclusion: based on evaluation of the customer and retain samples, the customer¿s indicated failure mode for the needle not retracting with the incident lot was not observed.However, further investigation has been initiated relating to this issue.The investigation is still on-going and improvements will be made as the potential causes are identified.Root cause description: based on the investigation of the customer and retain samples, a root cause could not be determined.The product was found to be in conformance and meet release specifications.Bd is currently reviewing specific areas in the manufacturing process where the cause of this issue may have originated.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Manufacturer Narrative

Additional information / investigation: on march 15, 2018, bd conducted a tele-conference with htl regarding the complaints received on htl non-retraction.The previous investigation summary that was completed by htl indicated that they were pursuing further investigation through a new capa since the complaint incident lots were manufactured after the original capa corrections were implemented.However, further clarification is that these complaints were not confirmed as the devices that were received showed no defects that would interfere with the needle not retracting.Although htl did note that there was an issue with the drive spring, the issue was determined to not impact the retraction of the needle.Htl will continue to monitor and is conducting further review of the manufacturing process.

Manufacturer Narrative

Additional information was received for the medical device lot number.The following fields have been updated: medical device lot #: x9u92a3.Medical device expiration date: 07/31/2021.Device manufacture date: 11/09/2017.

• Brand Name: BD MICROTAINER® CONTACT-ACTIVATED LANCET
• Type of Device: LANCET
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7192098
• MDR Text Key: 97308158
• Report Number: 2243072-2017-00434
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2018

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?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 366592
• Device Lot Number: X9U92A3
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/15/2018
• Supplement Dates Manufacturer Received: 12/22/2017; 12/22/2017; 12/22/2017
• Supplement Dates FDA Received: 01/29/2018; 03/07/2018; 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention