MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE; HYPODERMIC SYRINGE

Catalog Number 301073

Device Problems Air Leak (1008); Loose or Intermittent Connection (1371); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Three potential lot numbers were provided for this incident.The information for each lot number is as follows: medical device lot #: 7151817; medical device expiration date: 05/31/2022; device manufacture date: 05/31/2017.Medical device lot #: 7157513; medical device expiration date: 05/31/2022; device manufacture date: 06/06/ 2017.Medical device lot #: 7157517; medical device expiration date: 05/31/2022; device manufacture date: 05/31/2017.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 the stopper on a bd luer-lok¿ syringe was found defective "not tight" causing air bubbles.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: sample evaluation: nine loose 3ml assembled syringes were received by bd (b)(4) from unknown batch #.The reported batches were either #7151817 or 7157513 or 7157517 (p/n 301073).The samples were visually evaluated.During the evaluation the plunger/stopper assembly was moved to verify function.No defects were found.Bag 1 ¿ ¿from pack plungers deformed¿ ¿ 3 syringes.No visual defects observed.Bag 2 ¿ ¿syringes from pack keep getting air bubbles¿ ¿ 2 syringes.One syringe had a blank label attached.No visual defects observed bag 3 ¿ ¿from pack defective allows air around the plunger¿ ¿ 4 syringes.No visual defects observed.1 of the 4 syringes was a monoject syringe which was not manufactured at canaan.A label was attached to this syringe which read ¿good from or.¿ no defects were found or observed during this evaluation.Based on descriptions, the samples were potentially used and contaminated therefore no additional functional testing was performed.Dhr review for batch 7151817 (p/n 301073): manufacturing date: 6/2/2017 to 6/3/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7151817 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Dhr review for batch 7157513 (p/n 301073): manufacturing date: 6/17/2017 to 6/26/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7157513 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Dhr review for batch 7157517 (p/n 301073): manufacturing date: 7/09/2017 to 7/12/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7157517 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Based on the sample evaluation: ¿ unconfirmed: bd (b)(4) was not able to duplicate or confirm the customer's indicated failure.Investigation conclusion: root cause undetermined.

• Brand Name: BD LUER-LOK¿ SYRINGE
• Type of Device: HYPODERMIC SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7298183
• MDR Text Key: 101165092
• Report Number: 1213809-2018-00062
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301073
• Device Lot Number: SEE SECTION H.10.
• Date Manufacturer Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other