MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD; INTRAVASCULAR CATHETER

Catalog Number 306499

Device Problem Short Fill (1575)

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

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that an unspecified number of syr 10 ml fil saline short length plunger rod were pre-filled with less medication than specified.The following information was provided by the initial reporter: material no: 306499, batch no.: 8317513.Verbatim: 5 out of 30 syringes ¿ had broken flanges.These are approved syringes as the volume appears to be off by 0.4ml-0.5ml in the syringe module.¿ when pulled back to approx.5ml ¿ seeing a volume of 4.57 ml being reported by the modules.

Event Description

It was reported that an unspecified number of syr 10 ml fil saline shortlength plunger rod were pre-filled with less medication than specified.The following information was provided by the initial reporter: material no: 306499 batch no.: 8317513.Verbatim: 1.5 out of 30 syringes ¿ had broken flanges.2.These are approved syringes as the volume appears to be off by 0.4ml-0.5ml in the syringe module.¿ when pulled back to approx.5ml ¿ seeing a volume of 4.57 ml being reported by the modules.

Manufacturer Narrative

Investigation: three samples were received.All three have no barrel flange damaged or any other defect.They were measured for fill volume giving: 10.13ml, 10.46ml and 10.47ml.All of them are within product specification.Additionally, two photos were provided.One photo shows a shelf box and the other one a syringe in its packaging flow wrap with the barrel flange damaged.The barrel flange damage is usually from the plunger rod labeler process.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

Manufacturer Narrative

The date of event has been updated.The following information has been updated: date of event.

Event Description

It was reported that an unspecified number of syr 10 ml fil saline short length plunger rod were pre-filled with less medication than specified.The following information was provided by the initial reporter: material no: 306499.Batch no.: 8317513.Verbatim: 1.5 out of 30 syringes ¿ had broken flanges.2.These are approved syringes as the volume appears to be off by 0.4ml-0.5ml in the syringe module.¿ when pulled back to approx.5ml ¿ seeing a volume of 4.57 ml being reported by the modules.

• Brand Name: SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8584395
• MDR Text Key: 146680571
• Report Number: 1911916-2019-00447
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903064991
• UDI-Public: 00382903064991
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 306499
• Device Lot Number: 8317513
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other