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

Catalog Number 515400

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

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.(b)(4).

Event Description

It was reported that the assembly fixture m12 was used to attached a protector to the darzalex, causing a crack on the bottom of the vial that leaked.The following information was provided by the initial reporter, translated from (b)(6) to english: "a pharmacist, who prepares anticancer drug on a daily basis, attached a protector to the darzalex (400 mg) vial using assembly fixture, and this caused a crack on the bottom of the vial, resulting in leakage.".

Manufacturer Narrative

H6: investigation summary: one photo which displays a broken vial along with one assembly fixture was returned to our quality team for investigation.The product was visually inspected, no damage or defects were observed on the device.Functional testing was performed, connecting a protector to a vial using the m12 assembly fixture, the protector was successfully attached without issue.Product undergoes 100% inspection prior to release, including verifying the functionality of the vial holders.A review of device records was performed for lot 1910001, all product was verified to be manufactured according to specification, no issues related to the reported issue were identified.Based on the investigation and sample evaluation, we cannot identify a root cause related to the assembly fixture or our process at this time.H3 other text : see h10.

Event Description

It was reported that the assembly fixture m12 was used to attached a protector to the darzalex, causing a crack on the bottom of the vial that leaked.The following information was provided by the initial reporter, translated from japanese to english: "a pharmacist, who prepares anticancer drug on a daily basis, attached a protector to the darzalex (400 mg) vial using assembly fixture, and this caused a crack on the bottom of the vial, resulting in leakage.".

• 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: 11369517
• MDR Text Key: 258530312
• Report Number: 3003152976-2021-00104
• Device Sequence Number: 1
• Product Code: ONB
• 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: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1