MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD EMERALD¿ 10ML SYRINGE WITH LUER SLIP TIP

Catalog Number 307736

Device Problems Break (1069); Aspiration Issue (2883)

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

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

The date of event is unknown.The date received by the manufacturer is used.The device manufacture date is may, 2015.Device evaluation: a sample was received by the manufacturing site on 12/17/2015.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that a staff nurse was attempting to obtain a blood sample from a 4fr single lumen power picc which was inserted (b)(6) 2015.The nurse was initially unable to aspirate blood with a syringe so she flushed the picc with 2 x 10mls 0.9% saline and good blood return was established.She then attached bd emerald 10ml luer slip tip syringe into the hub of the picc in order to obtain a blood sample.The syringe severed and the syringe tip remained in the hub of the picc.The staff nurse attempted to remove the retained tip of the syringe with a scalpel but was unsuccessful.She then contacted the senior iv access nurse who removed the syringe tip from the picc hub with forceps.The decision was made to remove the picc with the patient's agreement due to potential risk of syringe fragments remaining.A second picc was then placed.

Manufacturer Narrative

Result - the affected sample was returned to the manufacturer.The evaluation of the device showed the syringe tip was broken, the end remaining in the other device.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 1505383.Conclusion - the customer's reported issue is confirmed by bd.The material used to manufacture emerald syringes has been selected and tested to resist normal conditions of use.The assembling machines have an on-line detection system that inspects 100 % the syringes, rejecting automatically the syringes with broken parts like the tip of the barrel.Based on this fact, the engineer has determined that the syringe tip could break as a consequence of any imperceptible damage in the barrel.This may be caused by some inappropriate handling condition or transport of the product before use.

• Brand Name: BD EMERALD¿ 10ML SYRINGE WITH LUER SLIP TIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5324896
• MDR Text Key: 34323597
• Report Number: 3002682307-2015-00003
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 307736
• Device Lot Number: 1505383
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2015
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention