MAUDE Adverse Event Report: BECTON DICKINSON 5 ML BD DISCARDIT II¿ SYRINGE W/NEEDLE 24G X 1 IN; HYPODERMIC SYRINGE AND NEEDLE

Catalog Number 300847

Device Problems Difficult to Remove (1528); Material Separation (1562)

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

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: n/a.(b)(6).Investigation: bd received 1 photo and one representative sample from the customer facility for investigation.Visually inspected (b)(4) samples for any loose cannula on the needle for lot 17a2711 & all samples found in ok condition.The complaint history for the lot# 17a2711 was reviewed and till date no complaint had been registered against the above lot for the defect- damage product.Dhr was reviewed for the product test.The entire routing test for reported lot found within the specification limit.No discrepancy was reported and recorded in dhr in customer reported lot # 17a2711.Log sheet ¿ no problem is recorded in assembly process during manufacturing of lot # 17a2711.Preventive maintenance- preventive maintenance conducted as per schedule.Stoppages ¿ no stoppages occurred in primary packaging process during manufacturing of lot # 17a2711.Bd was able to duplicate or confirm the customer¿s indicated failure mode.The team reviewed the primary packaging process of syringe and confirmed that no damage in needle is generated during the primary packaging operation.Also, process control related to primary packaging found within the process limit.Cannula pull force is checked during the after sterile testing.The pull force tested on instron machine is meeting the requirement limit of = 2.5 kgf.Also, the customer returned representative sample (same needle batch 6333038) was tested for cannula pull force and found 7.39kgf against specification limit of = 2.5 kgf.The defect rate is very low, hence can be considered as isolated case with stringent quality inspection.The team will monitor the defect and if defect rate increases will take actions appropriately.Customer return photograph showed evidence of damage product i.E.Cannula removed from needle, whereas the representative sample passed in cannula pull force on instron machine.

Event Description

It was reported that during use of the 5 ml bd discardit ii¿ syringe w/needle 24g x 1 in the needle separated from the syringe and remained in the patient.Doctors were unable to remove the needle by hand so patient was sent to surgery to have the needle removed.This delayed the originally scheduled procedure.There was no report of additional treatment or patient outcome.

• Brand Name: 5 ML BD DISCARDIT II¿ SYRINGE W/NEEDLE 24G X 1 IN
• Type of Device: HYPODERMIC SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6877719
• MDR Text Key: 86699171
• Report Number: 2243072-2017-00126
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 300847
• Device Lot Number: 17A2711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2017
• Initial Date FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• 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): Hospitalization; Required Intervention