MAUDE Adverse Event Report: BECTON DICKINSON, S.A. ASSEMBLY FIXTURE M12; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515400

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 2 assembly fixtures m12 were mixed with incorrect product.The following information was provided by the initial reporter: "two time the customer has received a wrong product.".

Manufacturer Narrative

The following fields were updated due to additional information: d.4.Medical device lot#: 1910002, 1910003.H.6.Investigation: three fixtures and one photo was provided to our quality team for investigation.Through visual inspection of the photo, the label displays item 515400 m12 assembly fixture and the product within was confirmed to be item 515400.Two additional fixtures were received in an alternate package, however, both fixtures were verified to be item 515400.A review of device records was performed for lots 1910003 and 1910002, all product was verified to be manufactured according to specification.Product undergoes 100% inspection before release, including verification of the proper product labeling, no issues were identified related to the reported issue.Based on our quality team's investigation and the sample evaluation, no product defect was identified as the case labeling and product within was verified to be item 515400.H3 other text : see h.10.

Event Description

It was reported that 2 assembly fixtures m12 were mixed with incorrect product.The following information was provided by the initial reporter: "two time the customer has received a wrong product.".

• Brand Name: ASSEMBLY FIXTURE M12
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 11478707
• MDR Text Key: 253593269
• Report Number: 3003152976-2021-00137
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515400
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1