MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE - W¿ WINGED YEL 24GA X 0.75IN; INTRAVASCULAR CATHETER

Catalog Number 381312

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Swelling (2091); Reaction, Injection Site (2442)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

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 of the bd insyte - w¿ winged yel 24ga x 0.75in a patient was infused with sugar and saline using insyte on the back of the hand after discharge from the hospital patient family found a small white spot on the puncture point on 02-12, according to family description puncture site was a little red on the first day of removal of needle.Doctor prescribed medicine baiduobang.On 02-19, patient's puncture site had black scab, skin was red and swollen, temperature was not high, there was no sense of fluctuation, and touched a little hard.At this time, the blood was normal.Transfer to municipal children's hospital for treatment.

Event Description

It was reported that during use of the bd insyte - w¿ winged yel 24ga x 0.75in a patient was infused with sugar and saline using insyte on the back of the hand after discharge from the hospital patient family found a small white spot on the puncture point on 02-12, according to family description puncture site was a little red on the first day of removal of needle.Doctor prescribed medicine baiduobang.On 02-19, patient's puncture site had black scab, skin was red and swollen, temperature was not high, there was no sense of fluctuation, and touched a little hard.At this time, the blood was normal.Transfer to municipal children's hospital for treatment.

Manufacturer Narrative

H.6.Investigation: 2 representative samples (unopened) were returned for investigation.No defect/ abnormality was observed on the returned sample.Dhr review was performed and no qn was raised for the batch.The returned samples were subjected to packaging water leak test.The samples passed packaging water leak test, no leakage was observed.The package integrity is intact.The cos showed that the batch had passed the sterility test.The complaint is unconfirmed and product is within the specification.

Manufacturer Narrative

The following fields have been updated due to corrected information: type of reportable events : serious injury.

Event Description

It was reported that during use of the bd insyte - w¿ winged yel 24ga x 0.75in a patient was infused with sugar and saline using insyte on the back of the hand after discharge from the hospital patient family found a small white spot on the puncture point on 02-12, according to family description puncture site was a little red on the first day of removal of needle.Doctor prescribed medicine baiduobang.On 02-19, patient's puncture site had black scab, skin was red and swollen, temperature was not high, there was no sense of fluctuation, and touched a little hard.At this time, the blood was normal.Transfer to (b)(6) hospital for treatment.

• Brand Name: BD INSYTE - W¿ WINGED YEL 24GA X 0.75IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8403767
• MDR Text Key: 138235556
• Report Number: 8041187-2019-00214
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903813125
• UDI-Public: 30382903813125
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 381312
• Device Lot Number: 8136223
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 02/19/2019; 02/19/2019
• Supplement Dates FDA Received: 05/03/2019; 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention