MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ ORAL DISPENSING SYRINGE 3 ML; ORAL SYRINGE

Catalog Number 305220

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device evaluated by mfr: 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 was reported that bd¿ oral dispensing syringe 3 ml scale markings are easily erased.The following information was provided by the initial reporter: they are reviewing the first batch that has arrived from the new plastic syringes that the customer are going to include in their "risperidone solution cases" and they have detected that the ink is very easily erased when handling them.They have erased the ink completely without too much effort.Units: 50000 oral syringe 3 ml clear ref.305220.Delivery: april 30, 2019.They sampled 315 units.The problem is that the ink is easily erased on all of them, since they all have the same ink impression.The lot we have received is 50000 units.

Manufacturer Narrative

Investigation: 30 loose 3ml oral syringes were received and visually evaluated.No visual defects were observed.All scale markings were present as per product design and specification.Additionally, three photos were received and evaluated.The 30 samples were tested for scale marking permanency per procedure.All 30 samples passed with no ink coming off.Three loose 3ml syringes were depicted in the photos.The syringes had liquid residue inside and had been manipulated.One syringe had faded print around words ¿oral use¿ and few of the grad lines next to those words.One syringe had missing print between 0.7ml and 2½ ml, centered approximately around 1½ ml location.One syringe had almost no print remaining, with only portions of ¿½¿ ml marking and ¿1¿ visible.All visual inspections were performed and no quality notifications related to the complaint defect were found during dhr review.Based on the information available, potential root cause for the reported defect is likely associated with end user manipulation of the product outside its intended use.No manufacturing defects could be confirmed at this time.

Event Description

It was reported that bd¿ oral dispensing syringe 3 ml scale markings are easily erased.The following information was provided by the initial reporter: they are reviewing the first batch that has arrived from the new plastic syringes that the customer are going to include in their "risperidone solution cases" and they have detected that the ink is very easily erased when handling them.They have erased the ink completely without too much effort.Units: 50000 oral syringe 3 ml clear ref.305220.Delivery: (b)(6) 2019.They sampled 315 units.The problems that the ink is easily erased on all of them, since they all have the same ink impression.The lot we have received is 50000 units.

• Brand Name: BD¿ ORAL DISPENSING SYRINGE 3 ML
• Type of Device: ORAL SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8654732
• MDR Text Key: 147202283
• Report Number: 1213809-2019-00577
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 07/17/2019

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: Other
• Device Catalogue Number: 305220
• Device Lot Number: 8354820
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 05/15/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other