MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC; INTRAVASCULAR CATHETER

Catalog Number 383746

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

H.3.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 pegasus pnk 20gax1.16in prn-capy non-pvc needle cap dislodged.The following information was provided by the initial reporter, translated from chinese to english: the patient underwent pelvic contrast hyperbaric injection of iohexol en route to the needle cap dislodged, resulting in incomplete injection of the drug and affecting the diagnosis of the disease.

Manufacturer Narrative

1.Dhr/bhr review: (1) the batch number of the complained product is 3093694, is 20g and product code is 383746, produced on 2023/05, with a total of (b)(4) pieces in this batch; (2) check the process inspection and delivery inspection report.The test results all meet the product standards and there are no abnormalities; (3) check the production records, there were no nonconformance, deviation or rework activities.2.No samples or pictures were returned.3.Test the cap torque of the retain sample, the test results meet the product specifications.4.The history of customer complaints for the same batch of products has been reviewed, and no complaints of the same defects have been found.5.Pegasus plus products with straight specifications can withstand 300psi pressure, and the connector need to be unscrewed during use.Sku#: 383746 is a y-shaped specification of pegasus plus product, which is clinically used for peripheral venous infusion.The high-pressure injector used for this product will cause product leakage or damage, the instructions for use warn this.6.For the market demand, bd plant specially manufacture pegasus plus devices with straight specifications for power injectors.The code is 383740, 383747, 383745.In summary, no abnormality is found on process and the retained sample.Sku#: 383746 is a y-shaped specification of pegasus plus product, which is clinically used for peripheral venous infusion.The high-pressure injector used for this product will cause product leakage or damage.Therefore, the complaint cannot be confirmed to be related to product quality.

Event Description

No additional information provided.

• Brand Name: BD PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18744031
• MDR Text Key: 335812637
• Report Number: 3002601200-2024-00045
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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 Catalogue Number: 383746
• Device Lot Number: 3093694
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other