MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367281

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Swelling/ Edema (4577)

Event Date 02/28/2022

Event Type  Injury  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd had not received samples or photos from the customer for investigation.Therefore, 50 retention samples from bd inventory were evaluated by visual examination and no issues were observed for the indicated failure mode 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 non-conformances during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode.Bd was not able to identify a root cause for the indicated failure mode.Since the patient¿s allergic information is unknown and no abnormalities were found from our investigation of retains, dhr, we were unable to specify the cause of the reported event.As you understand, the material used for needles is stainless steel.Stainless steel is an alloy steel containing nickel, chromium, cobalt, copper, etc.With iron as its main component.It is presumed that patients who are allergic to these metals will have an allergic reaction when the needle is inserted.

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set the customer experienced an allergic reaction.The following information was provided by the initial reporter.The caller stated: he/she "experienced an allergic reaction due to the ingredients of product.".

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13725324
• MDR Text Key: 287588967
• Report Number: 2243072-2022-00332
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903672818
• UDI-Public: 50382903672818
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2022

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: Other
• Device Model Number: 367281
• Device Catalogue Number: 367281
• Device Lot Number: 1H1711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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