MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ANGIOCATH PLUS IV CATHETER; INTERVASCULAR CATHETER

Catalog Number 382412

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 bd angiocath¿ plus iv catheter experienced a loose needle that was noted during use.The following information was provided by the initial reporter: they said that moving of stylet is too smooth to use.It is dangerous to insertion.Sometimes the cap of catheter open, the stylet has fallen out smoothly.

Manufacturer Narrative

H.6.Investigation summary one photo was received by our quality team for evaluation.Upon investigation of the returned sample, no abnormalities were observed on the stylet.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.As the investigation was not able to confirm what the customer had experienced, a root cause could not be determined.If more samples are received in the future, the complaint will be re-opened and re-investigated.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd angiocath¿ plus iv catheter experienced a loose needle that was noted during use.The following information was provided by the initial reporter: they said that moving of stylet is too smooth to use.It is dangerous to insertion.Sometimes the cap of catheter open, the stylet has fallen out smoothly.

• Brand Name: BD ANGIOCATH PLUS IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10119378
• MDR Text Key: 195783361
• Report Number: 8041187-2020-00323
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382412
• Device Lot Number: 9298185
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 05/15/2020
• Supplement Dates FDA Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other