MAUDE Adverse Event Report: ANGIOCATH BL 22GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	381123
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that angiocath bl 22ga x 1.0in blood control feature was not working.The following information was provided by the initial reporter: they have said that when the catheter is in the animal they find it hard to get the bung that stops the blood to stay in the catheter.
Additional Manufacturer Narrative
H6: investigation summary a physical sample was available for evaluation but appears to have been lost in transit on its way to the manufacturing facility.Therefore, without a physical sample available for evaluation a thorough investigation could not be performed to verify the reported issue.Additionally, a definitive root cause could not be identified.A review of the device history record was performed for the reported lot, 9329998, and no quality issues were found during production.Based on the results of the investigation, a root cause has not been determined for the defect of this complaint.It should be noted that the angiocath product design was intended for use in humans.Considering that in the customer description the catheter is reported to have been in animal use.If a sample becomes available or is found by the shipping facility this investigation will be reopened and re-evaluated.In addition to the fact that no records were found that could cause this claim during the analysis of batch history and non-conformities, without samples or photos for analysis, it is not possible to confirm the defects reported in this complaint.H3 other text : see h10.
Event or Problem Description
It was reported that angiocath bl 22ga x 1.0in blood control feature was not working.The following information was provided by the initial reporter: they have said that when the catheter is in the animal they find it hard to get the bung that stops the blood to stay in the catheter.

• Brand Name: ANGIOCATH BL 22GA X 1.0IN
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12286153
• Report Number: 9610048-2021-00111
• Device Sequence Number: 17309347
• Product Code: FOZ
• UDI-Device Identifier: 00382903811236
• UDI-Public: 00382903811236
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: 381123
• Device Lot Number: 9329998
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1