MAUDE Adverse Event Report: BECTON DICKINSON IV SET/J/60DROP/2CQ/RE/F/SB/50CM/PB

Catalog Number 385703-ZAT

Device Problem Crack (1135)

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

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is atom.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.Medical device expiration date: unknown.Device manufacture date: unknown.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 iv set/j/60drop/2cq/re/f/sb/50cm/pb was cracked during used.

Manufacturer Narrative

The actual device was returned, and cracks were recognized in the tube.The cross section of the cracked part had a distorted shape.In addition, this product was conducting the all-in-one visual inspection just before putting it into individual packaging.From the shape of the cross section of the crack, etc., it was presumed that this event was cracked by locally being sandwiched between objects like forceps during use.As described in the package insert, handling may cause damage or cracking, so please be careful when handling the product.A review of the device history record could not be performed as a lot number was not provided for this incident.

Event Description

It was reported that iv set/j/60drop/2cq/re/f/sb/50cm/pb was cracked during used.

Event Description

It was reported that iv set/j/60drop/2cq/re/f/sb/50cm/pb was cracked during used.

Manufacturer Narrative

Correction: in the previously submitted mdr, sections were incorrectly referenced as the medical device expiration date and device manufacture date.This supplemental mdr is being submitted to correct those references to show the following: medical device expiration date device manufacture date.

• Brand Name: IV SET/J/60DROP/2CQ/RE/F/SB/50CM/PB
• Type of Device: IV SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8135610
• MDR Text Key: 129511621
• Report Number: 2243072-2018-01731
• Device Sequence Number: 1
• Product Code: LHI
• 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,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 385703-ZAT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other