MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD NEOFLON¿ IV CANNULA SYSTEM 24 G X 1 IN.; INTRAVENOUS CATHETER

Catalog Number 391350

Device Problem Difficult to Insert (1316)

Patient Problem Hypoglycemia (1912)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that during use, the neonatal medical team was not able to place a cannula due to difficult cannula insertion.The baby¿s blood glucose dropped to an unsafe level during attempts.The infant who was involved in this incident will be followed up as an outpatient to determine the effects of this incident with low blood glucose.A bolus of dextrose was administered as medical intervention.

Manufacturer Narrative

No return sample for investigation.The nonconformance cannot be confirmed as no sample was returned for investigation.Thus, no root cause can be determined.The complaint will be re-opened if the sample is returned for investigation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 7076167.A manufacturing review also revealed no abnormalities that could have influenced the reported issue.Capa # (b)(4) was issued to review the tubing material.

• Brand Name: BD NEOFLON¿ IV CANNULA SYSTEM 24 G X 1 IN.
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6907608
• MDR Text Key: 87981154
• Report Number: 8041187-2017-00121
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K850276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 391350
• Device Lot Number: 7076167
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other