MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 10ML SYRINGE LUER-LOK¿ TIP

Catalog Number 300912

Device Problems Air Leak (1008); Break (1069)

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

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 plunger of a bd 10ml syringe luer-lok¿ tip broke during use, causing air to enter the barrel.Use of the syringe was discontinued and there was no report of injury or medical interventions.

Manufacturer Narrative

Results: one unsealed 10ml packaged syringe was received by bd (b)(4) and confirmed to be from batch #7178906 (p/n 300912).The sample was visually evaluated.The syringe was found to have an insecure stopper.The stopper was not fully assembled to the plunger rod tip.Dhr review for batch 7178906 was completed for the incident lot and no issues were identified.Conclusion: an absolute root cause for this incident cannot be determined.Based on the severity assigned to this complaint and the results of the complaint lot history check, capa is not required at this time.

• Brand Name: BD 10ML SYRINGE LUER-LOK¿ TIP
• Type of Device: 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6988832
• MDR Text Key: 91251198
• Report Number: 1213809-2017-00216
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903009122
• UDI-Public: 30382903009122
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 300912
• Device Lot Number: 7178906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 70