MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 23G X 0.75IN (0.6 X 19 MM) ASEPTO

Catalog Number 388338

Device Problem Packaging Problem (3007)

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

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that 23g x 0.75in (0.6 x 19 mm) asepto had a damaged package which compromised sterility.The following information was provided by the initial reporter: "hair inside the package.".

Event Description

It was reported that 23g x 0.75in (0.6 x 19 mm) asepto had a damaged package which compromised sterility.The following information was provided by the initial reporter: "hair inside the package.".

Manufacturer Narrative

H.6.Investigation: 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, 0330261, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed what looked like a piece of hair inside of the packaging.Based off the provided photo the engineer was able to verify the reported defect.It was determined that this was a manufacturing defect that occurred during the packaging process.H3 other text : see h.10.

• Brand Name: 23G X 0.75IN (0.6 X 19 MM) ASEPTO
• Type of Device: NA
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 12186051
• MDR Text Key: 264264923
• Report Number: 9610048-2021-00105
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 388338
• Device Lot Number: 0330261
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1