MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRE-FILLED NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306593

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306593 and lot number 9206061.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Investigation conclusion: no samples were received.No photos were provided.Therefore, sample analysis couldn¿t be performed, and the symptom reported by the customer can¿t be confirmed.A review of the applicable fmea/eura ((b)(4)) indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.Root cause description: no sample was received; no photo was provided; with no sample analysis a root cause could not be offered.The inspections performed while producing this lot were all accepted.Rationale: based on the investigation carried out and with no sample for analysis the symptom reported by the customer can not be confirmed.No additional actions will be taken other than monitoring the complaint trend for this lot.This lot was produced for (b)(4) units; therefore, the cpm is 1.4.

Event Description

It was reported that the bd¿ pre-filled normal saline syringe plunger was found broken when opening the packaging before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the child was admitted to the hospital for treatment and observation due to convulsion once on (b)(6) 2020.After infusion, the child was given a prefilled syringe to seal the tube.The plunger was broken after opening the package, so it was replaced immediately".

• Brand Name: BD PRE-FILLED NORMAL SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10519177
• MDR Text Key: 207388839
• Report Number: 1911916-2020-00859
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 306593
• Device Lot Number: 9206061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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
• Patient Outcome(s): Other