MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP-TIP SYRINGE NS; PISTON SYRINGE

Catalog Number 304086

Device Problem Volume Accuracy Problem (1675)

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

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 82,362 bd¿ slip-tip syringes ns were found with illegible scale print.The following information was provided by the initial reporter: "this is to inform that we found 82,362ea defective pieces with printing illegible in different areas".

Manufacturer Narrative

H6: investigation summary: two photos were received and evaluated.One photo displayed four 10ml syringes (p/n 304086) with print missing in various areas of the printed scale and the informational text.The second photo displayed two 10ml syringes with print missing in the informational text.The print appeared to be scraped off in all instances and the condition observed was non-conforming per product specification.Potential root cause for the missing print defect is associated with poor barrel feeding because of worn-out vibration blocks and improper paddle switch setup in response to the worn-out vibration blocks on the barrel feeder bowl leading to constant vibration/overfeeding.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

It was reported that 82,362 bd¿ slip-tip syringes ns were found with illegible scale print.The following information was provided by the initial reporter: "this is to inform that we found 82,362ea defective pieces with printing illegible in different areas.".

• Brand Name: BD¿ SLIP-TIP SYRINGE NS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13498255
• MDR Text Key: 285714185
• Report Number: 1213809-2022-00062
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K980987
• 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: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 304086
• Device Lot Number: 1336692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2021
• 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