MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM; CATHETER

Catalog Number 383019

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/01/2021

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 was reported that bd intima-ii y 22gax1.00in prn/ec slm was used and the patient experienced an allergic reaction.The following information was provided by the initial reporter: on (b)(6) 2021, the closed venous indwelling needle was applied and fixed with indwelling needle.About 10 minutes later, different sizes of (b)(6) appeared at the puncture site of the indwelling needle.3% boric acid solution was wet applied and tramisin cream was applied externally according to the doctor's advice.

Event Description

It was reported that bd intima-ii y 22gax1.00in prn/ec slm was used and the patient experienced an allergic reaction.The following information was provided by the initial reporter: on (b)(6) 2021, the closed venous indwelling needle was applied and fixed with indwelling needle.About 10 minutes later, different sizes of pimple herpes appeared at the puncture site of the indwelling needle.3% boric acid solution was wet applied and tramisin cream was applied externally according to the doctor's advice.

Manufacturer Narrative

H6: investigation summary : a device history review was conducted for lot number 0231182.Our records show that this is the only instance of this issue occurring in this production batch.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.H3 other text : see h10.

• Brand Name: BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12724075
• MDR Text Key: 282832763
• Report Number: 3014704491-2021-00232
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2021

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: 08/31/2023
• Device Catalogue Number: 383019
• Device Lot Number: 0231182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/29/2021
• Supplement Dates Manufacturer Received: 10/31/2021
• Supplement Dates FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• 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