MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 24G X 0.75IN (0.7 X 19 MM) INSYTE; INTERVASCULAR CATHETER

Catalog Number 381312

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

Patient Problems Erythema (1840); Fall (1848); Complaint, Ill-Defined (2331); Reaction (2414); No Code Available (3191)

Event Date 02/14/2019

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 the 24g x 0.75in (0.7 x 19 mm) insyte caused a reaction in the patient.The customer stated, "the patient was new born baby((b)(6)-old) of jaundice.On (b)(6) 2019 patient treatment drug is monosialotetrahexosyl ganglioside sodium injection 2 ml, with 10% glucose solution 10 ml qd,using insyte punctured on the hand back.Nurse found skin red in the infusion, then removed the needle.Nurse found a small white spot on the puncture site and periphery red, then nurse treat with iodophor disinfection and baiduobang.A lot of milky pus was squeezed out, and the skin on the back of the hand became red and patient left hospital on (b)(6) morning.The child was in a bad mental state, had a fever and had a high blood count on the evening of (b)(6).He was transferred to the (b)(6) hospital immediately.

Manufacturer Narrative

Investigation: 2 representative samples (unopened) were returned for investigation.No defect/ abnormality was observed on the returned sample.Dhr was performed and no qn was raised for the reported 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.

Event Description

It was reported that the 24g x 0.75in (0.7 x 19 mm) insyte caused a reaction in the patient.The customer stated, "the patient was new born baby(9-day-old) of (b)(6).(b)(6) 2019 patient treatment drug is monosialotetrahexosyl ganglioside sodium injection 2 ml, with 10% glucose solution 10 ml qd,using insyte punctured on the hand back.Nurse found skin red in the infusion, then removed the needle.Nurse found a small white spot on the puncture site and periphery red, then nurse treat with iodophor disinfection and baiduobang.A lot of milky pus was squeezed out, and the skin on the back of the hand became red and patient left hospital on (b)(6) morning.The child was in a bad mental state, had a fever and had a high blood count on the evening og 02-15.He was transferred to the (b)(6) hospital immediately.

• Brand Name: 24G X 0.75IN (0.7 X 19 MM) INSYTE
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8401472
• MDR Text Key: 138207982
• Report Number: 8041187-2019-00211
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903813124
• UDI-Public: 00382903813124
• 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
• 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?: Yes
• 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: 03/07/2019
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other