MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿; HYPODERMIC SYRINGE

Catalog Number 309658

Device Problem Connection Problem (2900)

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

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).Investigation: dhr review for batch #7120875 (p/n 309658): manufacturing dates: 5/12/2017 ¿ 5/13/2017.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7120875 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Sample evaluation: various samples in their original sealed packaging received and evaluated: - two 10ml plastipak syringes from lot #1706012p (p/n 305959) ¿ not canaan product.- three 5ml plastipak syringes from lot #7086514 (p/n 309649) ¿ canaan¿s product.- three 3ml plastipak syringes from lot #7120875 (p/n 309658) ¿ canaan¿s product.- three bd eclipse needles with smartslip from lot #1705003 (p/n 305760) ¿ not canaan product.Visual inspection did not reveal any defects in any of the samples received.A bd eclipse needle was then attached to different syringe samples, including 10ml, 5ml, and 3ml.It was observed that when being attached to the 3ml samples, the hub tightened sooner than when attaching to 5ml or 10ml samples.The connection was still secure.There was no difficulty connecting the needle up to the point it felt tight for any of the samples.The investigation discovered that the luer collar was the same in all of the samples and has no taper.The difference between the samples was the syringe tip, which has a taper.An iso 594/1 ring gage tool was used to verify the taper on all of the samples.The 3ml samples were at the lower end of the range than the 5ml and 10ml samples, which means the 3ml samples have a slightly higher degree of taper ¿ the tip widens faster.This would explain the observed difference when connecting to needle hubs and other luer lock devices.The result would be the tips on the 3ml syringes completing the connection sooner than 5ml or 10ml used in this investigation.However, all samples were within the specified iso range and all of the samples are acceptable for use.It is not recommended to force any devices past the point of a snug, secure connection.Based on the sample evaluation: unconfirmed: bd canaan was not able to duplicate or confirm the customer's indicated failure.Based on the fact that no defect was found, capa is not required at this time.Udi#: (b)(4).

Event Description

It was reported that the bd 3ml plastipak¿ syringe luer-lok¿ is difficult to connect with needle.There is concern for leakage from poor connection.There was no report of exposure, injury or medical interventions.

• Brand Name: BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿
• Type of Device: HYPODERMIC 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: 6925626
• MDR Text Key: 90090361
• Report Number: 1213809-2017-00161
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 309658
• Device Lot Number: 7120875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2017
• 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