MAUDE Adverse Event Report: BECTON DICKINSON BD DISCARDITII 5ML WITH 23X1; SYRINGE

Catalog Number 300852

Device Problem Leak/Splash (1354)

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

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the bd¿ discarditii 5ml with 23x1 has been found experiencing four occurrences of damaged product before use.The following has been provided by the initial reporter: when phlebotomist removing the product from package for drawing blood he found that barrel of the discardit ii 5ml23g syringe is cracked.

Manufacturer Narrative

H.6.Investigation: the samples were received by bd for evaluation.A quality engineer was able to review the returned samples of (2) discardit 5 ml 23g from lot # 9149827 product # 300852 with the reported issue of ¿when phlebotomist was removing the product from package for drawing blood, he found that barrel of the discardit ii 5ml23g syringe was cracked¿.Dhr reviewed found no non-conformities.Our team investigated the returned samples, photographs and the retention samples of material number 300852 for lot number 9149827.While the photograph confirmed the crack on the barrel on two of the returned samples, we did not find any defect in the retention samples.The defect is confirmed on the photograph received.After a thorough investigation and review of received complaint samples it is clear the barrel is cracked and complaint is confirmed.Although our machine already has a cracked barrel detection system, there may be a possibility of cracked barrel generation after detection system.Potential root cause is not identified for the defect but probable root cause may be that the syringe got stuck somewhere in transfer conveyer.As cracked barrel is a critical defect so the following actions are proposed to avoid cracked barrel defect: 1.Syringe transfer mechanism changed from pneumatic to servo to reduce shock and for smooth transfer of syringe.2.Also awareness training is provided to all the concern associate to check the material frequently for effectiveness of change.H3 other text : see h.10.

Event Description

It has been reported that the bd¿ discarditii 5ml with 23x1 has been found experiencing four occurrences of damaged product before use.The following has been provided by the initial reporter: when phlebotomist removing the product from package for drawing blood he found that barrel of the discardit ii 5ml23g syringe is cracked.

• Brand Name: BD DISCARDITII 5ML WITH 23X1
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9521780
• MDR Text Key: 177850537
• Report Number: 2243072-2019-02897
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

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: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 300852
• Device Lot Number: 9149827
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other