MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ 10 ML BULK PACK LUER LOCK TIP WITHOUT SAFETY; PISTON SYRINGE

Catalog Number 301029

Device Problems Volume Accuracy Problem (1675); Defective Device (2588); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Lot number was not reported; however, potential lot numbers were provided.The information for those numbers is as follows: medical device lot #: 1111285.Medical device expiration date: mar 31 2026.Device manufacture date: apr 30 2021.Medical device lot #: 1152292.Medical device expiration date: may 31 2026.Device manufacture date: june 30 2021.Medical device lot #: 1111296.Medical device expiration date: apr 30 2026.Device manufacture date: may 27 2021.Medical device lot #: 1239987.Medical device expiration date: aug 31 2026.Device manufacture date: sept 9 2021.Medical device lot #: 1270083.Medical device expiration date: aug 31 2026.Device manufacture date: oct 1 2021.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd luer-lok¿ 10 ml bulk pack luer lock tip without safety three syringes were found to be deformed and broken, one syringe had foreign matter contaminating the fluid pathway, and one syringe had unclear scale markings.The following information was provided by the initial reporter: material 301029 batch unknown ( possible lot 1111285, 1152292, 1111296, 1239987, 1270083).1 syringe bad print, 1 syringe ink contamination, 3 syringes deformed and broken.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 3/1/2022.H.6.Investigation: five 10 ml syringes (p/n 301029) were received.All the syringes were loose and one had the plunger rod separated from the barrel.One syringe was missing print from the 8ml to the 9.6ml grad lines and had ink dots on the opposite side of the grad lines.One syringe had twelve ink dots.One syringe had a vertical crack on barrel and loose plunger rod.One syringe had half of one rib on the plunger rod missing and was partially missing the thumb rest.The last syringe had a two vertical crack.The conditions observed were non-conforming per product specification.Potential root cause for the scale marking defects is associated with the printing process and potential root cause for the damaged components is associated with the assembly process.Batches 1111285, 1152292, 1111296, 1239987 and 1270083 are considered in compliance with our product specification requirements.A device history record review showed no rejected inspections or quality issues during the production of the provided batch numbers that could have contributed to the reported defect.H3 other text : see h.10.

Event Description

It was reported while using bd luer-lok¿ 10 ml bulk pack luer lock tip without safety three syringes were found to be deformed and broken, one syringe had foreign matter contaminating the fluid pathway, and one syringe had unclear scale markings.The following information was provided by the initial reporter: material 301029 batch unknown ( possible lot 1111285, 1152292, 1111296, 1239987, 1270083).1 syringe bad print, 1 syringe ink contamination, 3 syringes deformed and broken.

• Brand Name: BD LUER-LOK¿ 10 ML BULK PACK LUER LOCK TIP WITHOUT SAFETY
• 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: 13559019
• MDR Text Key: 286020388
• Report Number: 1213809-2022-00085
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301029
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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