MAUDE Adverse Event Report: BECTON DICKINSON EXT/RED/1CQ/MQ/STD/20CM; EXTENSION TUBING

Catalog Number 385403-ZAT

Device Problem Complete Blockage (1094)

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

Event Date 08/09/2019

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 and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.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 saline wouldn't flow through the ext/red/1cq/mq/std/20cm before use while priming.The following information was provided by the initial reporter, translated from (b)(6) to english: "saline didn't flow, during priming.".

Event Description

It was reported that saline wouldn't flow through the ext/red/1cq/mq/std/20cm before use while priming.The following information was provided by the initial reporter, translated from japanese to english: "saline didn't flow, during priming.".

Manufacturer Narrative

H.6.Investigation summary: the end of the infusion set made by our company (lock connector) was connected to the actual product, and it was confirmed that the fluid passed through.Visual inspection was performed, but no abnormality such as damage or deformation was found.Since no abnormality was found in this product and reproducibility was not obtained, this event was presumed to have been a problem with the fitting part with the infusion set connected to this product.The incomplete connection and loosening of the mating part may have caused the q-site septum to open inadequately and the chemical solution may not flow.When connecting to an infusion set or syringe made by another company, the septum opening may be small due to differences in the length of the lock connector insertion part.The customer should be careful not to apply excessive load during use, and use the product while regularly checking for any looseness or disconnection of the connection or leakage of chemicals.A review of the device history record revealed no irregularities during the manufacture of the reported lot.H3 other text : see section h.10.

• Brand Name: EXT/RED/1CQ/MQ/STD/20CM
• Type of Device: EXTENSION TUBING
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8946161
• MDR Text Key: 176256283
• Report Number: 2243072-2019-01851
• 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
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 385403-ZAT
• Device Lot Number: 1903032C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other