MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381123
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that three bd angiocath¿ peripheral venous catheter package seal unit was opened where sterility of the product is compromised.The following information was provided by the initial reporter: this is a report about open packages of angiocath.According to the customer's report, several packages were found to be already open before use.
Event or Problem Description
It was reported that three bd angiocath¿ peripheral venous catheter package seal unit was opened where sterility of the product is compromised.The following information was provided by the initial reporter: this is a report about open packages of angiocath.According to the customer's report, several packages were found to be already open before use.
Additional Manufacturer Narrative
H6: investigation summary: bd received three 22 gauge angiocath device from lot 1168743 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed that small openings in the blister packages.Therefore, based off the visual inspection the engineer was able to verify the reported defect.Unfortunately, the engineer could not identify a definitive root cause for this defect.The package seal was inspected and adhesive was observed along with the proper sealing mark to indicate that sealing had taken place normally, along with no findings in the manufacturing record to indicate a packaging issue.The manufacturing facility has been notified of this incident and the findings.

• Brand Name: BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15272018
• Report Number: 9610048-2022-00097
• Device Sequence Number: 15071845
• Product Code: FOZ
• UDI-Device Identifier: 00382903811236
• UDI-Public: 00382903811236
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: 05/31/2026
• Device Catalogue Number: 381123
• Device Lot Number: 1168743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2021
• 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
• Patient Sex: Unknown