MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381211

Device Problems Crack (1135); Fluid/Blood Leak (1250); Kinked (1339); Application Program Problem: Medication Error (3198)

Patient Problem Underdose (2542)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A sample is available for evaluation but has not yet been received.However, the manufacturing site in (b)(4) has completed a no sample investigation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6053177.A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment that could have influenced the customer's reported issue.An absolute root cause cannot yet be determined as the device evaluation on the available sample has nit yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that due to a crack and kink in a 24 g x.75 in bd insyte¿ peripheral iv catheter caused a leakage, and the patient was switched from iv antibiotics to oral antibiotics.There was no report of harm or additional medical interventions provided to the patient.

Manufacturer Narrative

Results: one used sample in opened packaging, and one unused sample in a closed packaging was returned for evaluation.A visual inspection of the used unit showed a kinked catheter.The actual sample also passed a leak test.A visual inspection of the of the unused sample showed no abnormalities.A device history record showed no quality notifications with this batch.A manufacturing review showed no abnormalities.Conclusion: the root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer's indicated failure mode.The catheter was kinked on the catheter tubing but passed the catheter leak test.

• Brand Name: 24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER
• Type of Device: INTRAVASCULAR 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: 6603047
• MDR Text Key: 76374226
• Report Number: 8041187-2017-00047
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 381211
• Device Lot Number: 6053177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• 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): Required Intervention