MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 50ML CATHETER TIP BRAZIL; SYRINGE, PISTON

Catalog Number 303553

Device Problems Break (1069); Fracture (1260)

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

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f27 ¿ no patient involvement device problem code: a040101 ¿ fracture.

Event Description

Product has cracked piston.

Event Description

No additional information received.Product has cracked piston.

Manufacturer Narrative

Pr (b)(4) follow up.A device history record review was completed by our quality engineer team for provided material number 303553 and lot number 3004161.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.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.H3 other text : see h10 narrative.

Event Description

Product has cracked piston.____ customer provided to us the information below.¿ could you send photos and/or videos that show the deviation in the product? please, see attached.¿ is the incident-related sample available for analysis? if so, respond: yes.

Manufacturer Narrative

Pr 9138004 follow up for device evaluation it was reported the product had a cracked piston.To aid in the investigation, one sample in an opened packaging blister and one photo was provided for evaluation by our quality team.A visual inspection was performed, and the syringe plunger rod has one of the ribs damaged.The photo provided shows the sample received.No other defects or imperfections were observed.This defect could occur if there was a jam during the assembly process.A device history record review was completed for provided material number 303553, lot 3004161.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.The sample will be shown to associates for awareness.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: SYRINGE 50ML CATHETER TIP BRAZIL
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18059537
• MDR Text Key: 327264127
• Report Number: 1911916-2023-00820
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903035533
• UDI-Public: (01)00382903035533
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 303553
• Device Lot Number: 3004161
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1