MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 10ML SALINE FILL; PREFILLED SALINE SYRINGE

Catalog Number 306595

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: a device history record review was performed for provided lot number 175460.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this incident, one picture sample was provided for evaluation by our quality team.The picture shows two syringes with the packaging flow wrap and in the picture, the flow wrap is damaged.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.The cause for this defect could have resulted during the packaging process, where the pick heads may have induced the damage observed in the photo.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.Investigation conclusion: based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.We will continue monitoring the complaint trend for the product and symptom.Probable root cause.It could be possible that at the packaging process the pick heads may have induced the damage observed in the photo.

Event Description

It was reported that 9 syringe 10ml saline fill experienced damaged or open unit packaging/seals where sterility was compromised.The following information was provided by the initial reporter: after receiving the goods, the head nurse opened the single box package and found that there was a single product in the clean package that was not sealed, and then opened the remaining boxes.There were unsealed products in them, totaling 9 products of 5 boxes were found and immediately contacted bd personnel to retrieve them.

• Brand Name: SYRINGE 10ML SALINE FILL
• Type of Device: PREFILLED SALINE SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11325284
• MDR Text Key: 232827156
• Report Number: 1911916-2021-00120
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 306595
• Device Lot Number: 0175460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1