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

Model Number	381134
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/24/2020
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 is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that foreign matter was found in the angiocath pnk 20ga x 1.16in before use.The following information was provided by the initial reporter, translated from (b)(4) to english: "381134, batch: 7241836, there are foreign objects in this product.".
Event or Problem Description
It was reported that foreign matter was found in the angiocath pnk 20ga x 1.16in before use.The following information was provided by the initial reporter, translated from chinese to english: "381134, batch: 7241836, there are foreign objects in this product.".
Additional Manufacturer Narrative
H6: investigation summary: bd received a 20 gauge angiocath unit from lot 7241836 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 unit and observed a piece of foreign matter inside the package.The piece of foreign matter was inspected and determined to be piece of cardboard.Based off the visual inspection the engineer was able to verify the reported defect.It was determined that this was an operator error that occurred during the packaging process.The manufacturing facility has been notified of this incident and the findings.A training was issued to all packaging operators to raise awareness of this issue and prevent recurrence.

• Brand Name: ANGIOCATH PNK 20GA X 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 10687970
• Report Number: 9610048-2020-00143
• Device Sequence Number: 3457145
• Product Code: FOZ
• UDI-Device Identifier: 30382903811343
• UDI-Public: 30382903811343
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (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): 10/28/2020

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: 08/31/2022
• Device Model Number: 381134
• Device Catalogue Number: 381134
• Device Lot Number: 7241836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other