MAUDE Adverse Event Report: BECTON DICKINSON IV SET CFN404 BP Y-CONN HS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 59013822

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2018

Event Type  malfunction  

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 in sections and the (b)(4) fda registration number has been used for the manufacture report number.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 the box of iv set cfn404 bp y-conn hs was packaged with "cfn120 products".

Manufacturer Narrative

H.6.Investigation summary: no samples was returned to hanscent, photos was sent from bd korea, lot number is 20180509.Warehouse samples checking: hanscent conducted sampling checks on warehouse inventory (192 cartons of cfn115, total 48000 pcs), with sample size 13 cartons, no packaging error was found.Device history record review: hanscent reviewed the manufacturing records for sku 59012922 lot 20180509 and sku 59013822 lot 20180509, no abnormality was observed.Root cause: from investigations, the defect occurred in the packaging process.The packing worker replace a carton when he was packing cfn 120 (59012922) due to carton damage, but failed to inform the workshop supervisor as per hanscent's procedure, and the replacement carton was made with a cfn404 (59013822) instead by mistake.The packing worker failed to follow proper procedure of replacing damage carton.Subsequently, the pallet worker discovered a carton of cfn 404 when he was palletizing cfn 120, thus he removed the carton of cfn 404, and placed it in the cfn 404 pallet.Thus, end customer found cfn 120 in cfn 404 box.Corrective actions: 1.Hanscent will work with bd korea on replacement of correct cfn 404 iv sets to customers if required.2.Hanscent will inspect product packing in product to ensure no mixed up as per aql i (0.1).Preventive actions: 1.Retrain the packing workers to inform workshop supervisor as the procedure required and establish a sheet to record the carton replacement.2.Retrain the pallet workers of the procedure to inform the workshop supervisor when he finds any different product with the pallet info , then the pallet will be quarantined until the pqc reviews it and gives conclusion.Conclusion: no samples was returned to hanscent, pictures were send from bd korea.From investigations, the defect occurred in the packaging process.The packing worker replace a carton when he was packing cfn 120 (59012922) due to carton damage, but failed to inform the workshop supervisor as per hanscent's procedure, and the replacement carton was made with a cfn404 (59013822) instead by mistake.The packing worker failed to follow proper procedure of replacing damage carton.Subsequently, the pallet worker discovered a carton of cfn 404 when he was palletizing cfn 120, thus he removed the carton of cfn 404, and placed it in the cfn 404 pallet.Thus, end customer found cfn 120 in cfn 404 box.

Event Description

It was reported that the box of iv set cfn404 bp y-conn hs was packaged with "cfn120 products".

• Brand Name: IV SET CFN404 BP Y-CONN HS
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8234875
• MDR Text Key: 132919350
• Report Number: 2243072-2018-01948
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

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 Expiration Date: 05/08/2021
• Device Catalogue Number: 59013822
• Device Lot Number: 20180509
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 01/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other