MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD¿ INTIMA-II Y 24GAX0.75IN PRN/EC SLM; INTERVASCULAR CATHETER

Catalog Number 383033

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

Patient Problems Arrhythmia (1721); Erythema (1840); High Blood Pressure/ Hypertension (1908); Swelling (2091); Reaction (2414); Constipation (3274)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one bd¿ intima-ii y 24gax0.75in prn/ec slm has been found causing an allergic reaction during use.The following has been provided by the initial reporter: on (b)(6) 2019, the patient was admitted to the hospital due to "decreased gastric absorption for one month and constipation for 10 days", and the admission was diagnosed as " lack of appetite (cause); hypertension level 3 (very high risk); arrhythmia (frequent premature ventricular beats); constipation (check for cause); lumbar spondylolisthesis ".At 14:55 on (b)(6), the nurse found that there was redness and swelling at the puncture site of the infusion on the right side of the patient's head, and the swelling range was about 10*9cm.It was found that the infusion liquid was fatty milk, and about 50ml had been injected.The patient did not report pain, and there was no redness around the puncture site.0.9% sodium chloride injection and 100ml+ dexamethasone 10mg was applied to wet compress the head, and the head of the bed was raised 60°.Skin swellness of the patient was closely observed.

Event Description

It has been reported that one bd¿ intima-ii y 24gax0.75in prn/ec slm has been found causing an allergic reaction during use.The following has been provided by the initial reporter: on (b)(6) 2019, the patient was admitted to the hospital due to "decreased gastric absorption for one month and constipation for 10 days", and the admission was diagnosed as "1.Lack of appetite (cause); 2.Hypertension level 3 (very high risk); 3.Arrhythmia (frequent premature ventricular beats); 4.Constipation (check for cause); 5.Lumbar spondylolisthesis ".At 14:55 on december 31th, the nurse found that there was redness and swelling at the puncture site of the infusion on the right side of the patient's head, and the swelling range was about 10*9cm.It was found that the infusion liquid was fatty milk, and about 50ml had been injected.The patient did not report pain, and there was no redness around the puncture site.0.9% sodium chloride injection and 100ml+ dexamethasone 10mg was applied to wet compress the head, and the head of the bed was raised 60°.Skin swellness of the patient was closely observed.

Manufacturer Narrative

H.6.Investigation summary a device history review was conducted for lot number 9106918.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.

• Brand Name: BD¿ INTIMA-II Y 24GAX0.75IN PRN/EC SLM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 9643705
• MDR Text Key: 182220859
• Report Number: 3006948883-2020-00036
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830336
• UDI-Public: 382903830336
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Catalogue Number: 383033
• Device Lot Number: 9106918
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other