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); Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: unknown.Initial reporter e-mail: unknown.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 5 bd posiflush¿ normal saline syringes had illegible/smeared packaging print, with one label directly pressed into a plunger rod, fracturing it.The following information was provided by the initial reporter, translated from chinese: "in the pediatric hematology department, when the product package was opened, the printing misalignment of the product was found.The printed label was directly pressed into the push rod to fracture the push rod.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 17-nov-2022.H6: investigation summary it was reported the printed label was directly pressed into the plunger inducing plunger rod damage.To aid in the investigation, one sample with no packaging flow wrap, and two photos were received for evaluation by our quality team.A visual inspection was performed and the plunger rod is damaged at the top part below the thumb press.One of the plunger rod ribs has a piece of the packaging flow wrap adhered to it.The two photos provided show the sample received.No other defects or imperfections were observed.This defect could occur if the spacing of the flow wrapper was not correct inducing the defect reported.A device history record review was completed for provided material number 306595, lot number 2045240.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the packaging flow wrap process was performed.The settings were correct, and the flow of product was good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

Event Description

It was reported that 5 bd posiflush¿ normal saline syringes had illegible/smeared packaging print, with one label directly pressed into a plunger rod, fracturing it.The following information was provided by the initial reporter, translated from chinese: "in the pediatric hematology department, when the product package was opened, the printing misalignment of the product was found.The printed label was directly pressed into the push rod to fracture the push rod.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15585206
• MDR Text Key: 301548812
• Report Number: 1911916-2022-00564
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065950
• UDI-Public: (01)00382903065950
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306595
• Device Lot Number: 2045240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2022
• 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