MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 20ML LL W/FRESENIUS LABEL; SYRINGE, PISTON

Catalog Number 301998

Device Problem Fracture (1260)

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

Event Date 08/17/2023

Event Type  malfunction  

Event Description

Unpacked syringe to block a demers catheter.It was noticed that there was a torn edge on the syringe cone and a crack on the upper edge of the syringe.Recla.Samples: available, if you are interested please send us the shipping details.Pictures: see attachment.

Manufacturer Narrative

Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.

Event Description

No additional information received.

Manufacturer Narrative

Investigation summary: photos of 20 ml syringes received by our quality team for investigation.Through visual inspection, tip of syringes are cracked and damaged, therefore the incident is confirmed.A device history review was performed for lot cbil24100 , no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the teams investigation, possible root cause is related with a hit during transport or manufacturing.Areas where pieces are transported in manufacturing area are protected to avoid damage on the product.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.

• Brand Name: SYRINGE 20ML LL W/FRESENIUS LABEL
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18658609
• MDR Text Key: 334745979
• Report Number: 3003152976-2024-00063
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 301998
• Device Lot Number: CBIL24100
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1