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

Catalog Number 306595

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: a device history record review was completed for provided material number 306595 and lot number 0175459.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, three physical samples and one photo were provided for evaluation by our quality team.The three samples received are in the packaging flow wrap and have the barrel flange damaged.The photo shows eight syringes in the packaging flow wrap.From the photo provided it is not possible to observe the barrel flange damaged.Investigation conclusion: based on the investigation with the sample analysis the symptom reported by the customer is confirmed.Root cause description: it could be possible for this defect to occur if there is a misalignment at the plunger rod infeed inducing the barrel flange damage.There are quality controls currently in place to detect this type of defect during the production process.Rationale: further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd posiflush" normal saline syringe barrel was broken.The following information was provided by the initial reporter, translated from (b)(6) to english: "the rear end of the plastic shell outside the syringe is broken.The department where the problem occurred is orthopedics.The contact information of the department staff was not provided.The product with the same problem has two different batch numbers.It is not possible to confirm which product is pricked the operator's hand.".

• Brand Name: BD POSIFLUSH 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 ; 8015296192
• MDR Report Key: 11143877
• MDR Text Key: 229833358
• Report Number: 1911916-2021-00012
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2021
• 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: 0175459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2020
• 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