MAUDE Adverse Event Report: BECTON DICKINSON BD IV SET/N35/20DROP/L; IV ADMINSITRATION SET

Catalog Number 515540-ZAT

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: 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 there was a mix of products with a bd iv set/n35/20drop/ll.This was discovered prior to use.The following information was provided by the initial reporter: 515568-zat product got mixed in the shelf carton of 515540-zat.

Manufacturer Narrative

H.6.Investigation summary: 515568-zat and the product listed on the individual packaging were recognized in the photo.This product was 515568-zat as well as individual packaging.The specifications of this product did not differ between the 515540-zat and 515568-zat, except for the inner and outer diameters of the tube.In addition, the production number and production record confirmed that the packaging and sterilization processes for these two items were performed on the same date and time.Therefore, it was estimated that this event was caused by the product being mixed due to some mishandling of the workers after bagging, and shipping with the label check omissions overlapped.Since there was no abnormality in the production record, it could not be determined whether this event was only one or 515568-zat was not mixed with 515540-zat.We decided to collect the product number that had been packed and sterilized.If a mis-packed product was used without being aware of it, it could result in a different infusion volume from the intended flow rate.As measures to prevent recurrence, we identified items with similar appearance and started source management that separated production dates by three days or more.In addition, an inspector was assigned to confirm that the product is the same product using the product name and serial number on the label immediately before packing.H3 other text : see section h.10.

Event Description

It was reported that there was a mix of products with a bd iv set/n35/20drop/ll.This was discovered prior to use.The following information was provided by the initial reporter, translated from japanese to english: 515568-zat product got mixed in the shelf carton of 515540-zat.

• Brand Name: BD IV SET/N35/20DROP/L
• Type of Device: IV ADMINSITRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8782471
• MDR Text Key: 150981707
• Report Number: 2243072-2019-01392
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 515540-ZAT
• Device Lot Number: 1902282C
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other