MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. SYRINGE 10ML REG PR SALINE FILL SPKG; INTRAVASCULAR CATHETER

Catalog Number 306553

Device Problems Packaging Problem (3007); Illegible Information (4050)

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

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided lot number 0286402.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this issue, both picture and physical samples were returned for evaluation by our quality engineer team.Investigation conclusion: through examination of the samples, damage was observed to the product packaging.Upon receipt of this report, an awareness training session was performed with all applicable associates in regards to this defect.An increase in the frequency of in-process inspections has been temporarily established to monitor for the presence of this type of damage during the manufacturing process.A corrective and preventive action plan has been initiated to further investigate this issue and ensure that the corrective actions are addressing the issue properly.Root cause description: at this time, a single cause for this type of damage has not been assigned.Rationale: the existing capa (b)(4).Has been raised to track the corrective actions established for top web damage issue.The issue is being investigated with plant engineering leadership, and while a single root cause is unassignable, the capa has utilized ishikawa assessments and the current focus of the investigation is on the handling and packaging of the blisters.Corrective and preventive actions shall continue to be tracked through capa (b)(4).

Event Description

It was reported that syringe 10ml reg pr saline fill spkg package was damaged on 19 occasions and the label was smeared.The following information was provided by the initial reporter: material no: 306553, batch no: 0286402.It was reported 9 out of the 19 syringes have large holes in the sterility packaging, 10 out of 19 had the sterility packaging completely worn.The packaging was so worn that even the letters on the packaging had faded.We received shipment and opened up the box to inspect the materials & we found 19 of these syringes had to be we rejected.9 out of the 19 have large holes in the sterility packaging, complete breaches of the sterile barrier; 10 out of 19 had the sterility packaging completely worn from shipping and were about to tear.The packaging was so worn that even the letters on the packaging had faded.

• Brand Name: SYRINGE 10ML REG PR SALINE FILL SPKG
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11396541
• MDR Text Key: 241749419
• Report Number: 9616657-2021-00027
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065530
• UDI-Public: 00382903065530
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2021

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 306553
• Device Lot Number: 0286402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2020
• 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