MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH PNK 20GA X 1.16IN; CATHETER

Catalog Number	381134
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that angiocath pnk 20ga x 1.16in leaked blood.The following information was provided by the initial reporter: we have received customer complaints regarding the two products below.Both calls have reported the same issue.Once inserted into the patient and bunged, the catheter will either leak iv fluid or blood from the patient.
Event or Problem Description
It was reported that angiocath pnk 20ga x 1.16in leaked blood.The following information was provided by the initial reporter: we have received customer complaints regarding the two products below.Both calls have reported the same issue.Once inserted into the patient and bunged, the catheter will either leak iv fluid or blood from the patient.
Additional Manufacturer Narrative
H6: investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record could not be performed as the lot number was unknown.

• Brand Name: ANGIOCATH PNK 20GA X 1.16IN
• Common Device Name: CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 11773945
• Report Number: 9610048-2021-00069
• Device Sequence Number: 3998209
• Product Code: FOZ
• UDI-Device Identifier: 00382903811342
• UDI-Public: 00382903811342
• 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): 06/22/2021

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 Catalogue Number: 381134
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1