MAUDE Adverse Event Report: BECTON DICKINSON BD SENTRY SAFETY LANCET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 369523

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed.As high tech labs is an oem manufacturing site.(b)(4).Investigation summary: bd received 10 samples and 4 photos from the customer for investigation.The photos were reviewed and the indicated failure mode for improper assembly with the incident lot was observed.All customer samples were evaluated by visual examination and the issue of improper assembly was observed.The loose components were observed to have some mechanical damage.Two of the complete, already activated lancets had a broken protective cap.Additionally, retention samples from bd inventory were evaluated by visual examination and the issue of improper assembly was not observed.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 non-conformances during manufacturing of the product.

Event Description

It was reported that during use the lancet breaks off with 3 bd sentry¿ safety lancet.The following information was provided by the initial reporter, translated from (b)(4) to english: when using the lancet, it found that the needle was break off and the lancet has detachment phenomenon.

• Brand Name: BD SENTRY SAFETY LANCET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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 ; 8015652341
• MDR Report Key: 10510396
• MDR Text Key: 207790950
• Report Number: 2243072-2020-01382
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2020

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
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 369523
• Device Lot Number: Y47A940C3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2018
• 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): Other