MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 20ML LL BNS; SYRINGE, PISTON

Catalog Number 301031

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a0201 - product quality problem patient problem code: f27 ¿ no patient involvement possible lots - unknown which lot was used: 2032050.2032058.

Event Description

As agreed, at the end of the batch we report the discrepancies found.All reports were discovered during packaging, i.E.Before use.No patients involved.Article code: 301031 ll bns 20ml syringe.Batch: 2032050 & 2032058.Damaged syringe x 1.Crooked scale x 4.Missing stopper x 1.Samples are available and can be picked up if needed.

Event Description

No additional information received.As agreed, at the end of the batch we report the discrepancies found.All reports were discovered during packaging, i.E.Before use.No patients involved.Article code: 301031 ll bns 20ml syringe.Batch: 2032050 & 2032058.Damaged syringe x 1.Crooked scale x 4.Missing stopper x 1.Samples are available and can be picked up if needed.

Manufacturer Narrative

(b)(4) follow up for device evaluation.It was reported there was a damaged syringe, crooked scales and a missing stopper.To aid in the investigation, six samples with no packaging blisters were received for evaluation by our quality team.A visual inspection was performed.Four samples have a scale marking issue, one sample is missing the stopper, and one sample has rub marks at the top part of the syringe barrel.Rub marks are considered an acceptable imperfection.No other defects or imperfections were observed.The scale marking defect could occur if there was a jam during the syringe barrel printing process.The missing stopper could occur if there was a jam during the plunger rod-rubber stopper assembly process.A device history record review was completed for provided material number 301031, possible lots 2032050 and 2032058.The review did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.The samples will be shown to associates for awareness.To date, there have been no other similar events reported for these lots.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: SYRINGE 20ML LL BNS
• 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: 17950626
• MDR Text Key: 326015528
• Report Number: 1911916-2023-00777
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 50382903010313
• UDI-Public: (01)50382903010313
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

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: Health Professional
• Device Catalogue Number: 301031
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1