MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE 10ML SALINE FILL CE EMA/CIS SP; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306585

Device Problem Illegible Information (4050)

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

Event Date 10/26/2023

Event Type  malfunction  

Event Description

It was reported that bd syringe 10ml saline fill ce ema/cis sp unit package labeling issues.The following information was provided by the initial reporter, translated from polish to english: illegible print on the foil of the unit packaging (blurred, incomplete, double).

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.If additional information becomes available, a supplemental report will be filed.

Manufacturer Narrative

To aid in the investigation of this issue, two (2) pictures were received for evaluation by our quality team.Through examination of the pictures, the information printed on the packaging film was blurred and not legible.A device history record review was completed for provided material number 306585 and lot number 3199059.The review did not reveal any detected abnormalities during the production process that could have contributed to this reported incident.As no issues were detected during production, an exact cause could not be determined.This type of defect may occur with the packaging film at the end of the film roll, as tension is higher on the film due to the winding process.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

No additional information.

• Brand Name: BD SYRINGE 10ML SALINE FILL CE EMA/CIS SP
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18171018
• MDR Text Key: 328996125
• Report Number: 3002682307-2023-00330
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065851
• UDI-Public: (01)00382903065851
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: UKN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306585
• Device Lot Number: 3199059
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1