MAUDE Adverse Event Report: BD (SUZHOU) BD POWERME 22GA X 8CM Y Q-SYTE; MIDLINE CATHETER

Catalog Number 980020

Device Problem Crack (1135)

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

Event Date 10/11/2023

Event Type  malfunction  

Event Description

It was reported that bdpowerme 22ga x 8cm y q-syte cracked.The following information was provided by the initial reporter; the head nurse reported that during the use of the product, the product.The y-shaped interface and infusion connector cracked, causing leakage.Liquid, quantity 1, requires green claim settlement, investment required.Complaint reply letter, complaint acceptance letter is required, photos can be to provide, samples can be returned.

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.

Manufacturer Narrative

1.Production lot record check (lot#3016993) : 1) the product specification is 22gx8cm, sku number is 980020, the production date is (b)(6) 2023, and lot quantity is (b)(4).2) check the process test report and outgoing test report, the test results meet the product standards, no abnormalities.3) check production records for no nonconformities, deviations or rework activities.2.Return sample have been received, the device have been used.Y adaptor cracked per attached photo 1.3.Conducted manual test for retain sample, no crack issue.4.Root cause analysis: people:all the assembly operator for this batch have been quolified no people changed machine:checked production record for this batch, no machine equipment changed and repaired material:the cracked adaptor were molded by supplier rega, checked the incoming inspection record for this batch, no abnormality conducted clamping test to simulate the use of nurse for the same batch adaptor, the adaptor cracked same as customer complainted method: manufacturing procedure and inspection method no change for this bartch environment:checked production record for this batch, no abnormal with temperature and humidity.Confirmed with representative that the product storage environment in hospital no abnormal.Countermeasure: 1).Initiate global hold for all affected products.2.) initiate scar(#scar-fy24-001) to supplier rega for injection process improvement and expected to be closed in december.Refer to attached mail history.(after supplier analyzed and reappear experiment, the root cause is that the resin of adaptor stays in the barrel of injection machine for long time, caused resin degradation and the adaptor becoming brittle).3.) plant 100% sort the adaptor under quality plan #p-2102306 control before scar closed.H3 other text : see narrative.

Event Description

No additional information provided.

• Brand Name: BD POWERME 22GA X 8CM Y Q-SYTE
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18056639
• MDR Text Key: 327179676
• Report Number: 3014704491-2023-00687
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00382903830787
• UDI-Public: (01)00382903830787
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 980020
• Device Lot Number: 3016993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2023
• 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