MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383083

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: 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 during use it was discovered that there was no cap on the needle with an bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: on (b)(6) 2019, 09:44, (the patient) was admitted to the hospital due to diarrhea and nausea for 2 hours.When the nurses gave the patients transfusion, the bd indwelling needle was found no needle cap and needle bent after exhaustion the air.Replacement of bd indwelling needle at 15:06 after timely detection.No adverse consequences were caused to the patients and no needle injury was caused to the nurses.

Event Description

It was reported that during use it was discovered that there was no cap on the needle with an bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2019, 09:44,(the patient) was admitted to the hospital due to diarrhea and nausea for 2 hours.When the nurses gave the patients transfusion, the bd indwelling needle was found no needle cap and needle bent after exhaustion the air.Replacement of bd indwelling needle at 15:06 after timely detection.No adverse consequences were caused to the patients and no needle injury was caused to the nurses.

Manufacturer Narrative

Investigation summary.No actual sample returned, no defective picture returned.Cannot be verified which type of needle bent.The needle cover loose was caused by needle bent.Review the batch record, assembly date of this lot is (b)(6) 2018 and no needle bend were found in process inspection and fg inspection.There are have possibility of needle bent both in the process of plant and during transportation.For needle bend on process of plant.The angle of needle bend always below 10 degree and investigation team has been set up in (b)(6) 2018.The area where the needle bend may occur in the factory has been improved.The online inspection and final inspection found that the number of needle bend in the factory is getting less and less.The following area may cause needle bend in process of plant and we have taken actions.A.In packing process, the products bounced after placed on the formed base film and hit the machine protective cover.It caused needle bend.We have adjusted the height position of the protective cover of the machine to prevent the bumped product from coming into contact.The action has been finished on (b)(6) 2018.B.On shipping area of the plant warehouse, we found that the employees of the transportation company stepped on the case carton when they placed the needles on the top of the van.It will cause the needle bend in case carton.The plant has required the transportation company to use the ascending tool for bend in case carton.The plant has required the transportation company to use the ascending tool for loading, and it is strictly forbidden to step on the product.The action has been finished on (b)(6) 2018.(2) for the needle bend on transportation.The qa will lead the project to cooperate with our customer and take actions to improve the needle bend on transportation.The action still ongoing.(3)the current actions cannot eliminate such defects, so the plant is trying to assess the strength of the product.4.Check the retained samples 30 pcs, no find needle cover loose.Conclusion: for process of plant, we found no abnormal on needle bent.It was the needle bent on transportation.Confirmed defect: needle bent big angle 2.The defect of needle cover loose was never found in the production and inspection process, based on the needle bent complaints, which may be caused by transportation and other reasons, resulting in slight loosening of the needle cover.Confirmed defect: needle cover loose.Probable root cause: conclusion(s) it was the needle bent on transportation.The needle cover loose was caused by needle bent.Corrective and/or preventive action.Are corrective/preventive actions indicated? no conclusion(s) training material has been sent to dealers and shippers.Standardize transportation, end user operation behavior by marketing associates training.Establish a bd internal service line btw.Plant and sales rep.To quick response.Marketing department is required to provide continuous training and promotion to dealers, transporters and frontline representatives.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 8965145
• MDR Text Key: 156913873
• Report Number: 3006948883-2019-00726
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2021
• Device Catalogue Number: 383083
• Device Lot Number: 8079067
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other