MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 5ML SALINE FILL CHINA SP; PREFILLED SALINE SYRINGE

Catalog Number 306594

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 2 syringe 5ml saline fill china sp experienced missing label information which was noted during use.The following information was provided by the initial reporter: on (b)(6) 2020, a nurse in the respiratory department found that there was no label on the wall of the tube of the prefilled catheter irrigator during the operation of flushing and sealing the tube, and neither of the two products lined up together had any label.Then she reported to the head nurse of the department and contacted the supplier.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 10/7/2020.H.6.Investigation: a device history record review was completed for provided material number 306594 and lot number 0003308.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, one physical sample was received for evaluation by our quality team.The sample came in the sealed packaging flow wrap and is missing the barrel label.Based on the investigation results, the sample received did show the symptom reported by the customer.It could be possible for this defect to occur during the plunger rod labeler process.When the machine stops and restarts again it could have a missing barrel label.H3 other text : see h.10.

Event Description

It was reported that 2 syringe 5ml saline fill china sp experienced missing label information which was noted during use.The following information was provided by the initial reporter: on (b)(6) 2020, a nurse in the respiratory department found that there was no label on the wall of the tube of the prefilled catheter irrigator during the operation of flushing and sealing the tube, and neither of the two products lined up together had any label.Then she reported to the head nurse of the department and contacted the supplier.

• Brand Name: SYRINGE 5ML SALINE FILL CHINA SP
• Type of Device: PREFILLED SALINE SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10604188
• MDR Text Key: 210668148
• Report Number: 1911916-2020-00907
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 306594
• Device Lot Number: 0003308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 09/07/2020
• Supplement Dates FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other