MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ASEPTO¿ SCALP INFUSION SET; INTRAVENOUS INFUSION SET

Catalog Number 388339

Device Problem Packaging Problem (3007)

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

Event Date 08/04/2021

Event Type  malfunction  

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.

Event Description

It was reported that the bd asepto" scalp infusion set punctured through the packaging unit.The following information was provided by the initial reporter, translated from (b)(6) to english: "extension of the material sealed with the packaging, breaking it.".

Event Description

It was reported that the bd asepto¿ scalp infusion set punctured through the packaging unit.The following information was provided by the initial reporter, translated from portuguese to english: "extension of the material sealed with the packaging, breaking it.".

Manufacturer Narrative

H6: investigation summary: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 1032509, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the tube was cut and sticking out from the edge of the packaging.Based off the provided photo the engineer was able to verify the reported defect.It was determined that this was an operator error that occurred during the packaging process.H3 other text : see h10.

• Brand Name: BD ASEPTO¿ SCALP INFUSION SET
• Type of Device: INTRAVENOUS INFUSION SET
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12407225
• MDR Text Key: 269493666
• Report Number: 9610048-2021-00122
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

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
• Device Operator: Other
• Device Catalogue Number: 388339
• Device Lot Number: 1032509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 10/19/2021
• Supplement Dates FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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